September 2010 |
| Date |
Event Title |
Location |
Details |
Contact |
| Sep 08 2010 - Sep 10 2010 |
Introduction to Molecular Biology Techniques |
King of Prussia, PA |
Molecular biology pertains to the study of living systems at the molecular level, especially DNA and RNA, and provides a background appropriate for further work in the rapidly expanding areas of genomics, cell biology, biotechnology, microbiology, diagnostics, and therapeutics. This course will focus on selected aspects of molecular biology that provide the non-specialist with the principles for understanding the structure and functional relationships of molecular biology techniques including DNA manipulation, sequencing, cloning, subcloning, library construction, screening, RNA isolation and characterization, analysis of expression, cDNA synthesis (RT-PCR) and analysis, microarrays and gene chips, and Real-Time-PCR. Multiple modern day molecular biology techniques in the biotechnology and pharmaceutical industries will be presented and several examples of molecular applications will be highlighted. |
http://www.cfpie.com/showitem.aspx?productid=051&source=labmate |
| Sep 08 2010 - Sep 10 2010 |
Technical Writing for Pharmaceutical, Medical Device and Biotech Industries |
Costa Mesa, CA |
Course notes and interactive exercises address how to write effective correspondence and reports in support of the company?s activities. You will learn how to organize and deliver information for the intended audience. You will learn how to write clear and readable documents, and how to revise and refine your own and others? writing. The course provides an overview of sound grammatical conventions, addresses problematic areas of the English language, and affords opportunities to address specific language issues. |
http://www.cfpie.com/showitem.aspx?productid=077&source=labmate |
| Sep 09 2010 - Sep 10 2010 |
Preparing the CMC Section for NDAs/CTDs/INDs |
Costa Mesa, CA |
This course includes an overview of the International Conference on Harmonization (ICH) process and the organization of the CTD, detailed information and discussions related to each element required in the drug substance and drug product sections of NDAs and INDs. The course will emphasize the requirements related to drug substance starting materials, drug substance and drug product specifications, impurities, stability, and pharmaceutical development reports. It will also discuss the use of Drug Master Files (DMF) and preparation of the CTD Quality Overall Summary (Module 2). |
http://www.cfpie.com/showitem.aspx?productid=061&source=labmate |
| Sep 15 2010 - Sep 17 2010 |
ADME, PK/TK, and Drug Metabolism in Drug Discovery and Development |
King of Prussia, PA |
The content of this course will assist pharmaceutical, biotechnology, and CRO researchers and managers in understanding the requirements for a well-designed and successful ADME, PK/TK, and DM program conducted within a drug development logic plan and in compliance with ICH guidelines. The various types of ADME, PK/TK, and DM studies, which include in vitro metabolism and delivery, animal and human pharmacokinetics, protein binding, mass balance, tissue distribution, metabolite isolation and identification and toxicokinetic support will be discussed.
Study designs and potential results, with possible interpretations, from each of the study types will be presented. The generation study reports and summaries, both of which are to be included in submissions to regulatory authorities for completed research experiments will be described in detail. |
http://www.cfpie.com/showitem.aspx?productid=090&source=labmate |
| Sep 15 2010 - Sep 16 2010 |
Financial Fundamentals for Non-Financial Personnel - How Financial Issues Impact Business |
King of Prussia, PA |
The content of this course will give each attendee a comprehensive introduction to business and finance. It covers the basics such as where cash comes from and how it flows through and leaves the business, the criteria required to make capital investment decisions, and how the business knows when it is successful in meeting strategic objectives. Real life business situations are introduced that directly reflect company specific performance and provide participants with an opportunity to apply new skills. The course director employs an interactive style, which will engage the participants and provide a lively atmosphere. |
http://www.cfpie.com/showitem.aspx?productid=036&source=labmate |
| Sep 15 2010 - Sep 16 2010 |
Medical Devices - EU Directives, Guidance, CE Marking and ISO Standard Certifications |
Costa Mesa, CA |
This is a two-day workshop focusing on understanding the requirements of the Medical Device Directives, their linkage to the EU Clinical Trial Directive and the requirements of CE Marking and ISO Certification on commercializing products. The course covers all relevant topics associated with the Directives and Guidance Documents, the reasons behind their introduction and a review of methods for effective implementation.
Key topics to be discussed include:
* The current regulatory situation in relation to Medical Devices in the EU
* The purpose of the Medical Device Directives
* Meeting the New Requirements for Conformity Assessment by Product Type
* Understanding the impact the Directive will have on developing and marketing new Medical Device products
* An overview of key areas of the Directive
o Scope of application and definition
o Essential Requirements
o Medical Device Type & Process Path
o Medical Device Technical File
o Clinical Investigations
o Clinical Evaluations
o Notified Bodies
* Gain a detailed understanding of all Guidance Documents available to assist in implementation of these directives |
http://www.cfpie.com/showitem.aspx?productid=092&source=labmate |
| Sep 15 2010 - Sep 16 2010 |
SFC 2010 |
Stockholm, Sweden |
4th International Conference on Packed-Column SFC
register@greenchemistrygroup.org
|
www.greenchemistrygroup.org |
| Sep 16 2010 - Sep 17 2010 |
Analytical Method Validation for Biologics, Biopharmaceuticals and Other Therapeutic Products |
Dublin, Ireland |
Complex processes yielding complex products such as biologics and biopharmaceuticals demand numerous, non-compendial, and sometimes complex, QC test methods to confirm manufacturing consistency and product quality. This course provides a comprehensive overview of the international regulatory authority requirements and expectations for test method validation of these assays. This course will prepare attendees with the knowledge and tools to plan and execute test method validation packages for the NDA, BLA and MAA market application dossiers, covering in-process, release and stability assays commonly used by QC in biologic and biopharmaceutical companies.
The course will cover validation of QC analytical test methods (e.g., electrophoretic, HPLC, peptide mapping, etc.), cell-based potency bioassays, immunochemical binding impurity assays and adventitious agent assays. |
http://www.cfpie.com/showitem.aspx?productid=096&source=labmate |
| Sep 16 2010 - Sep 17 2010 |
Pharmaceutical Production Batch Record Review |
Berlin, Germany |
Efficient and effective batch record reviews provide pharmaceutical companies with two strategies. First, reviews are key to maintaining control of your firm?s operations, eliminating any guesswork and aiding in the resolution of atypical occurrences. Secondly, they enable a company to maintain and demonstrate a compliant posture - a sure way to avoid any quandary with the regulatory agencies.
This course is intended to take the mystery out of the batch record review process. The class examines the FDA and EU regulatory requirements for documentation and batch record reviews, explains the elements of the batch record review process, and clarifies the pathway to effective deviation investigations. Interactive sessions are included for identifying reviewer responsibilities, establishing good documentation practices, and writing procedures for the review process. Additionally, participants will be able to analyze their company?s compliance with these requirements and identify missing elements of the batch review process.
Ample time is provided to address specific problems and questions of individual participants. |
http://www.cfpie.com/showitem.aspx?productid=058&source=labmate |
| Sep 20 2010 - Sep 22 2010 |
CMC Regulatory Compliance for Biopharmaceuticals and Biologics |
Dublin, Ireland |
With the rapid development and constantly changing Chemistry, Manufacturing & Controls (CMC) landscape, it is more important than ever for a company to have an effective strategy to achieve CMC regulatory compliance.
At each stage of drug development, from Phase 1 through market approval, one basic question needs to be addressed: ?What is absolutely necessary, from a CMC regulatory compliance perspective, to be successful in getting our biopharmaceutical/biologic through clinical trials and into the market?? CMC regulatory compliance deficiencies have resulted in clinical holds and delays in obtaining market approval. CMC shortfalls in marketed products have also resulted in FDA Warning Letters and product recalls. Insights and practical suggestions on how to develop and manage a clinical phase-dependent CMC regulatory compliance strategy for biopharmaceuticals and biologics are offered in this course.
This course also includes a discussion on preparing CMC sections for a market application dossier using the Common Technical Document (CTD) formatted Modules 2.3 and 3 for biopharmaceuticals and biologics. CMC compliance regulations and guidances from the U.S. FDA, EMEA and ICH are discussed. |
http://www.cfpie.com/showitem.aspx?productid=017&source=labmate |
| Sep 20 2010 - Sep 21 2010 |
Clinical Document Management ? A Trial by Trial Approach To Compliance |
King of Prussia, PA |
Companies in the business of conducting clinical trials must understand that each trial is different and requires trial-specific processes for gathering data, managing it, transporting it to the right place and archiving it. Trials require a complete web-work of documents and records, from contracts, protocols, investigator brochures, and standard operating procedures, to data collected during the conduct of the trial and transmitted to the Sponsor for analysis and regulatory use. Even if a Sponsor has a robust document management system, to be successful, a clinical trial must address records management unique to the study itself and incorporate the various resources allocated to the conduct of the trial. By the end of the course, participants should be able to do the following:
* Understand the documentation requirements for a trial based on the protocol and the geographical location
* Review and assess documentation needs in the context of paper, electronic and hybrid document management systems
* Understand the roles and responsibilities of the team members with regards to the trial documentation; understand those roles from the Sponsor, site and CRO perspective
* Determine what SOPs are required to run the trial and who has responsibility for them
* Know what the Essential Document list should be for the protocol you are testing
* Understand what the Trial Master File is made of and how this is different from the Essential Document list
* Be prepared for audits; site, CRO and in-process trial audits |
http://www.cfpie.com/showitem.aspx?productid=124&source=labmate |
| Sep 20 2010 - Sep 21 2010 |
Labeling and Labeling Controls for Medical Devices |
Costa Mesa, CA |
This course provides comprehensive and up-to-date knowledge of labeling development and subsequent control. The course covers regulatory expectations regarding labeling requirements in the FD and C Act, the Fair Packaging and Labeling Act, labeling for investigational devices, label control in the cGMP-QSRs and Part 801 (general controls).
This course will address labeling in terms of the following:
* Misbranding, False Or Misleading Labeling
* Prescription Device Labeling
* Sterile Devices
* Intended Use Affecting Design Decision-Making
* Label Writing ?Dos And Don?ts"
* Label Integrity
* Authorization
* Contractor-Produced Labels As A Linkage With Purchasing Controls
* Issuance
* Retention
* Submissions To The FDA
* Label Inspection |
http://www.cfpie.com/showitem.aspx?productid=106&source=labmate |
| Sep 20 2010 - Sep 21 2010 |
Validation of Computer Systems |
Dublin, Ireland |
This course focuses on developing and implementing regulated computer systems with an appropriate level of documented evidence to satisfy FDA expectations. The course targets deliverable document content and how to avoid rework and unnecessary expense through a proactive approach. The core elements of a satisfactory computer validation program will be emphasized.
Topics to be discussed include:
* The regulatory expectations for computer validation
* Relevant FDA warning letters
* The tasks and deliverables expected for computer validation
* Why validation processes vary so much
* Strategies for practical, yet defensible computer validation
* Sops required for system operation and maintenance
* 21 CFR part 11 and it?s implications for common regulations
* An active discussion of part 11 examples and audience questions
* The implications of GAMP 5 on computer validation and how to transition from GAMP 4
* Auditing GXP computer systems and suppliers |
http://www.cfpie.com/showitem.aspx?productid=081&source=labmate |
| Sep 21 2010 - Sep 22 2010 |
Introduction to Medical Device Submissions ? 510ks, PMAs, and Exemptions |
King of Prussia, PA |
This course covers current FDA regulatory compliance with respect to developing and marketing medical devices. A focus will be placed on relevant aspects of FDA regulations and the practical aspects of bringing a medical product to market.
The course will initially cover the general context for medical device regulations. Later, a more in-depth discussion will begin to look at each of the submission categories in detail. FDA?s regulations, guidance documents, and on-line informational resources will be highlighted and used throughout the course. |
http://www.cfpie.com/showitem.aspx?productid=127&source=labmate |
| Sep 21 2010 - Sep 22 2010 |
Preparation of FDA Submissions (INDs, NDAs, BLAs, ANDAs, Post-Approval Supplements) and Communicating with the FDA |
King of Prussia, PA |
This course will give participants the background and history of the US Food and Drug Administration (FDA) as a basis for the strategic planning of submitting INDs, NDAs, BLAs, ANDAs, and post-approval supplements. Each item of these submissions will be individualized, analyzed, and discussed in conjunction with their importance in relation to FDA regulations and guidances. Each item will be detailed as to how to best present data for successful FDA approvals.
Course content will include preparation for FDA meetings and the nuances of pharmaceutical industry interaction with the FDA. Chemistry Manufacturing and Controls (CMC), Nonclinical and Clinical areas will be covered. The Common Technical Document (CTD) formatting will also be discussed. |
http://www.cfpie.com/showitem.aspx?productid=085&source=labmate |
| Sep 22 2010 - Sep 24 2010 |
Technical Writing for Pharmaceutical, Medical Device and Biotech Industries |
Dublin, Ireland |
Course notes and interactive exercises address how to write effective correspondence and reports in support of the company?s activities. You will learn how to organize and deliver information for the intended audience. You will learn how to write clear and readable documents, and how to revise and refine your own and others? writing. The course provides an overview of sound grammatical conventions, addresses problematic areas of the English language, and affords opportunities to address specific language issues. |
http://www.cfpie.com/showitem.aspx?productid=077&source=labmate |
| Sep 22 2010 - Sep 23 2010 |
Purchasing Controls in the Medical Device Industry |
Costa Mesa, CA |
This workshop provides comprehensive and up-to-date knowledge of purchasing controls/acceptance activities and subsequent process control. The course covers regulatory expectations regarding the type and extent of control to be established and documented within an organization?s quality management system and the ramifications of outsourcing in the United States as well as the use of foreign platforms. When a medical device manufacturer chooses to utilize suppliers, the manufacturer should ensure control over any product or service obtained from such suppliers as defined within the quality management system. These controls may extend further if a supplier subcontracts work. |
http://www.cfpie.com/showitem.aspx?productid=119&source=labmate |
| Sep 22 2010 - Sep 23 2010 |
Software Development for Medical Device Professionals |
Costa Mesa, CA |
Upon completion of this course, you will have gained an understanding of how to effectively meet the requirements of software development design control for medical devices. Particular emphasis will be placed on effective design strategy, as all too often unnecessary time and money is spent on ineffective software design control processes.
The first day will cover topics including regulations and standards, software development, software development procedures and will include software development models and design controls. The second day will discuss software validation of development tools and software used in Manufacturing and throughout the Quality System as well as risk management for software-based medical devices.
Several interactive exercises are used to reinforce principles and concepts. |
http://www.cfpie.com/showitem.aspx?productid=071&source=labmate |
| Sep 23 2010 - Sep 24 2010 |
Best Practices for Facilities and Utilities Design, Qualification and Monitoring |
King of Prussia, PA |
Regulatory agencies hold firms responsible for delivering high quality products that meet all established requirements and specifications. The adequate selection, installation, qualification and continuous monitoring of the facilities and utilities are critical to our compliance with these criteria. Companies must apply the current industry perspective of a life-cycle approach to the implementation and operation of these systems to keep an adequate level of control throughout their life cycle.
Initially, this course will discuss the regulatory expectations and other industrial references/standards that will impact your systems, and will follow with a proposed project plan and detailed discussion of implementation steps. During these sections, attendees will establish documentation requirements for each phase of the project including specific needs for computerized control systems.
In conclusion, participants will learn validation maintenance aspects for these systems, focusing on adequate monitoring and change control management. During the course, several interactive exercises are included to provide opportunities for discussion and sharing of experiences. |
http://www.cfpie.com/showitem.aspx?productid=008&source=labmate |
| Sep 23 2010 - Sep 24 2010 |
Introduction to Medical Combination Products |
King of Prussia, PA |
This course covers current FDA regulatory compliance with respect to developing and marketing Combination Products. A focus is placed on relevant aspects of FDA regulations as well as the practical aspects of getting the Combination Product to market. Several example products will be highlighted to provide practical, hands-on instruction.
The first part of the course provides general context for the overall topics surrounding combination products. Later, a more in-depth discussion on implementation within a complete combination product development environment is presented. FDA?s regulations, guidance documents, and on-line informational resources will be highlighted and used throughout the course. |
http://www.cfpie.com/showitem.aspx?productid=126&source=labmate |
| Sep 23 2010 - Sep 24 2010 |
Stability Programs for Product Shelf Life - From Development to Approval |
King of Prussia, PA |
This continually updated course covers current FDA regulatory requirements and ICH guidelines as applied to designing stability programs from the early stages of product development all the way to approval. Among the topics to be discussed will be: identifying FDA?s regulations and ICH guidelines for stability testing, writing study protocols and SOPs, designing and validating stability indicating analytical test methods, establishing Successful Stability Data Management Systems, conducting and documenting OOS results and deviations, and preparing for an FDA inspection of stability program. |
http://www.cfpie.com/showitem.aspx?productid=072&source=labmate |
| Sep 27 2010 - Sep 28 2010 |
Writing Effective Standard Operating Procedures and Other Process Documents |
Dublin, Ireland |
This course presents a comprehensive overview of process writing that the binding regulations require. There?s a tenet among regulatory bodies: ?If you didn?t write it down, it didn?t happen,? and while the regulations tell companies what they need to do and document, they don?t tell them how. Determining how systems work and how processes occur and documenting them is up to companies to assess. This course presents process writing within the ?big picture? of controlled documentation and gives industry standards for delivering information. Effectively prepared process documents keep companies on track and compliant. Participants will learn how to write documents that ensure consistency in operations. A workshop in process writing gives participants the opportunity to actually write about a process and then assess the results.
The course also addresses problematic areas of the English language and affords participants the chance to voice their questions. Participants will learn how to tighten and refine the language to produce clear and comprehensive documents. |
http://www.cfpie.com/showitem.aspx?productid=083&source=labmate |
| Sep 27 2010 - Sep 28 2010 |
Adverse Drug Events ? Reporting & Regulatory Requirements |
Dublin, Ireland |
This course will provide participants with an understanding of drug safety at the investigational stage and during the marketing phase. Adverse event identification and reporting requirements will be addressed, as well as FDA, EMEA, Health Canada and ICH roles in the drug safety process. The course will also discuss international law/regulations, ICH guidelines, Pharmacovigilance, definitions and current regulatory issues.
Adverse Event reporting requirements specific to the US, Canada, Japan, and Europe will be discussed and compared in detail. Participants will be provided with templates for reporting requirements in each region covered.
Multiple exercises are included to reinforce the lecture material. Through the use of various scenarios, participants will learn how to assess and report AEs including SAEs. |
http://www.cfpie.com/showitem.aspx?productid=002&source=labmate |
| Sep 27 2010 - Sep 28 2010 |
Best Practices for an Effective Cleaning Validation Program |
King of Prussia, PA |
This course provides practical guidance on cleaning validation regulatory compliance, in conjunction with, risk-based, reasonable and informed decision making and activity planning. The program will describe the requirements for establishing an effective cleaning validation program, including the development of a general policy, a ?Cleaning Validation Master Plan? and the appropriate documentation for each study to be performed. In addition, requirements for maintenance of the validated status will be reviewed. Regulatory requirements and the latest industry practices will also be included in the discussion.
Cleaning validation examples from pharmaceutical, biologic and biopharmaceutical manufacturing processes will be included.
Additional benefits of this class include:
* All participants receive a Resource CD with templates for Cleaning Validation Plans, protocols and additional references
* Learn not just from the director, but tap into the knowledge of your peers: Participants will have the opportunity to discuss their challenges and problems
* Participants will also have the opportunity for one-on-one consulting with the course director during course breaks and in the evenings. The course director has over 24 years of industry experience, and over 14 years of consulting experience |
http://www.cfpie.com/showitem.aspx?productid=007&source=labmate |
| Sep 27 2010 - Sep 28 2010 |
Design Control for Medical Device Professionals |
Dublin, Ireland |
This continually updated course covers current FDA regulatory compliance with respect to developing medical devices. A focus will be placed on basic regulation and the FDA's supplemental guidelines.
Among the topics to be discussed are: context of design control within the overall quality system and regulation, design control procedures, forms, records, safety/risk management strategies, documentation strategies, manufacturing transfer strategies, and strategies for integrating general quality system procedures into design control. |
http://www.cfpie.com/showitem.aspx?productid=024&source=labmate |
| Sep 27 2010 - Sep 28 2010 |
Good Laboratory Practices (GLP) for Pre-Clinical Testing |
King of Prussia, PA |
This course will provide participants with a comprehensive understanding of the terminology, regulations and mandated practices for GLP testing and compliance. Those attending will get a thorough briefing of the relevance of accurate documentation, calibration and maintenance of instruments and validation of relevant methodology. Special attention will be paid to the critical compliance aspects of gathering pre-clinical data in a regulated environment.
Also included is a discussion of functions related to Quality Assurance Unit responsibilities and the need to effectively audit for regulatory compliance. Successful audits are often a result of good planning and interaction between QA staff and management. This course will cover a range of audit activities (internal and external) including responsibilities and requirements for compliance (plus those required at collaborator sites), records management, GLP special requirements, archiving of data and inspections. |
http://www.cfpie.com/showitem.aspx?productid=112&source=labmate |
| Sep 28 2010 - Sep 29 2010 |
The EU Clinical Trial Directive |
King of Prussia, PA |
This course focuses on understanding the requirements of the new EU Clinical Trial Directive and the issues inherent in any new regulatory process. The course covers all relevant topics associated with the Directive, the reasons behind its introduction and a review of methods for effective implementation.
Key topics to be discussed:
* The current regulatory situation in relation to clinical trials in the EU.
* The purpose of the new Clinical Trials Directive.
* Meeting the New Requirements for Chemical Authorization and Conduct
* Understanding the impact the Directive will have on running clinical trials
* An overview of key areas of the Directive:
- Regulatory approval/notification
- Ethical review
- Exemptions under the current arrangements
- Informed consent
- Good manufacturing practice
- Safety reporting
- Inspection
* Gain a detailed explanation of the key differences between ICH GCP and the new EU Directive |
http://www.cfpie.com/showitem.aspx?productid=030&source=labmate |
| Sep 29 2010 - Oct 01 2010 |
Good Manufacturing Practices |
King of Prussia, PA |
Good Manufacturing Practice regulations (cGMPs) are used by pharmaceutical, medical device and food manufacturers as they produce and test products that people use (Drug cGMPs also apply to the veterinary drugs). In the United States (U.S.) the Food and Drug Administration (FDA) has issued these regulations as the minimum requirements. This course explores the regulations through which the Federal government controls the drug, cosmetics and diagnostic industries. Major emphasis is placed on understanding the need for and the intent of regulations and developing mechanisms for implementation and compliance.
This course is intended to give participants an introduction to cGMP regulations and their application to laboratory studies and manufacturing processes. It will also provide participants with an understanding of terminology and the role GMPs play in assuring their validity. Those attending will also get an understanding of the needs for thorough and comprehensive training and documentation.
Additionally, this course introduces students to the principles of GLP/GMP in the pharmaceutical and associated industries with the emphasis on the necessary procedures and documentation required to achieve full compliance. |
http://www.cfpie.com/showitem.aspx?productid=113&source=labmate |
| Sep 29 2010 - Oct 01 2010 |
The Drug Development Process - From Discovery to Commercialization |
Dublin, Ireland |
The drug development process involves a series of lengthy steps that determine the degree of success for every drug brought to the market. Decisions made throughout the process affect every aspect of future development and impact heavily on commercialization strategies.
Included in the course content is an overview of the regulatory and pre-marketing steps that occur to ensure a successful launch. The course also covers sales planning and the commercialization decisions that affect the development of the drug. |
http://www.cfpie.com/showitem.aspx?productid=025&source=labmate |
| Sep 29 2010 - Sep 30 2010 |
Design Validation, Verification, and Risk Analysis for Medical Device Professionals |
Dublin, Ireland |
This course covers current FDA regulatory compliance with respect to developing medical devices. Focus will be placed on relevant aspects of FDA regulation to V&V and Risk Analysis and the FDA's supplemental guidelines. An ISO perspective is offered to compliment the FDA view.
Among the topics to be discussed are: Context of V&V and Risk Analysis within the overall quality system and regulation, V&V and Risk analysis procedures, V&V methodologies, V&V strategies, types of risk analysis, risk mitigation, and methods to determine probability and severity for Risk analysis. |
http://www.cfpie.com/showitem.aspx?productid=118&source=labmate |
| Sep 29 2010 - Sep 30 2010 |
Process Validation for Drugs and Biologics |
King of Prussia, PA |
Process validation is not a curse invented by regulators and pushed onto a company by QA staff. Instead, it is a legal requirement in the pharmaceutical industry. The concept of process validation is recognition that quality cannot be tested into the product and must be designed into the process/product to reduce the risk of non-conformances during/after manufacturing.
This course provides practical guidance on compliance with the requirements of process validation that lead to risk-based, reasonable and supportable informed decisions. Compliance with the requirement for process validation must go hand in hand with sound science for the proper evolution of critical processes.
The course includes process validation examples from pharmaceutical, biologic and biopharmaceutical manufacturing processes. This includes the manufacturing of the API and the finished drug products. |
http://www.cfpie.com/showitem.aspx?productid=049&source=labmate |
| Sep 30 2010 - Oct 01 2010 |
Effective Document Management for Pharmaceutical, Biotech, & Medical Device Industries |
Dublin, Ireland |
If you didn?t write it down, it didn?t happen! This is the position of the FDA and most regulatory agencies internationally. Good documentation is vital for doing business in the regulated world from discovery through marketplace. It is also important for due diligence and regulatory inspections, and is necessary for the success of your products and services. While the regulations tell you what you must do, they don?t tell you how. Based on industry best practices, this course clarifies how to refine your existing system, create a new one, or prepare to transition from a manual system to electronic controls.
This course also addresses what documents you need to control, what documentation you need to support your actual system and how to keep your documents current and compliant. |
http://www.cfpie.com/showitem.aspx?productid=027&source=labmate |
| Sep 30 2010 - Oct 01 2010 |
European Filing & Registration Procedures |
King of Prussia, PA |
This course specifically focuses on agencies that control the regulatory process. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in the EU and individual European countries. Content will include descriptions of the methods by which regulators in the corresponding agencies process filings and registrations.
The current regulatory climate will be discussed in depth and numerous examples will be provided to illustrate effective filing techniques. Common issues which have caused difficulties for pharmaceutical firms will be discussed. Course content will explain how the EU interacts with national regulatory agencies and how personnel can best address the conflicts that sometimes arise.
This course will also be useful for sales or general management personnel who need an overview of the registration process within the EU. |
http://www.cfpie.com/showitem.aspx?productid=031&source=labmate |
October 2010 |
| Date |
Event Title |
Location |
Details |
Contact |
| Oct 04 2010 - Oct 06 2010 |
Tablets & Capsules - Development, Manufacture and Testing of Solid Oral Dosage Forms |
Costa Mesa, CA |
This course provides comprehensive and up-to-date knowledge of development, manufacture, testing, release and/or registration of solid oral dosage forms of small molecule pharmaceuticals. The course covers formulation design considerations for tablets and capsules and unit operations utilized in the manufacture of the solid oral dosage forms. In addition, this course will cover the regulatory requirements for drug product registration (International Conference on Harmonization guidelines), including testing requirements, stability studies, and format/content of regulatory dossier for worldwide registration/approval (CTD format). This course will prepare attendees to design and execute effective formulation and process development plans for solid oral dosage forms. In addition, the course will address specific considerations in the development of challenging molecules, such as poorly water soluble drugs. The course will also cover development of specialized dosage forms such as modified release products and fast dissolve tablets. |
http://www.cfpie.com/showitem.aspx?productid=120&source=labmate |
| Oct 04 2010 - Oct 05 2010 |
Patent and Other Intellectual Property Law for the Life Sciences Industry |
King of Prussia, PA |
Upon completion of this course, attendees will have a clear understanding of intellectual property terminology as well as the nature and extent of intellectual property rights. Attendees will also gain the background knowledge necessary for taking the appropriate steps to protect the various types of intellectual property. With regard to patents, attendees will acquire a basic understanding of patent concepts, patentability requirements, the types and parts of a patent application, drafting a patent application, and the process of obtaining worldwide patent protection.
This course also discusses patent litigation and the role of the United States Patent and Trademark Office and federal courts, including the U.S. Court of Appeals for the Federal Circuit. |
http://www.cfpie.com/showitem.aspx?productid=048&source=labmate |
| Oct 04 2010 - Oct 05 2010 |
Practical Methods for Project Management |
King of Prussia, PA |
The following issues will be covered:
* Fostering team participation
* Creating a team contract
* Creating a charter
* Defining the scope of the project
* Setting scope boundaries
* Breaking down the work
* Determining who should be on the team
* Development of a deliverables schedule
* Estimating staff effort & spending
* Risk Assessment
* Creating countermeasures to reduce risk
* Managing changes to the plan
* How to monitor project progress
* Effective use and design of project status meetings
* Writing a status report
* Managing an issues list
* Capturing lessons learned
* Assembling a project plan
* Writing a close out report |
http://www.cfpie.com/showitem.aspx?productid=060&source=labmate |
| Oct 04 2010 - Oct 05 2010 |
Validation of Computer Systems |
Costa Mesa, CA |
This course focuses on developing and implementing regulated computer systems with an appropriate level of documented evidence to satisfy FDA expectations. The course targets deliverable document content and how to avoid rework and unnecessary expense through a proactive approach. The core elements of a satisfactory computer validation program will be emphasized.
Topics to be discussed include:
* The regulatory expectations for computer validation
* Relevant FDA warning letters
* The tasks and deliverables expected for computer validation
* Why validation processes vary so much
* Strategies for practical, yet defensible computer validation
* Sops required for system operation and maintenance
* 21 CFR part 11 and it?s implications for common regulations
* An active discussion of part 11 examples and audience questions
* The implications of GAMP 5 on computer validation and how to transition from GAMP 4
* Auditing GXP computer systems and suppliers |
http://www.cfpie.com/showitem.aspx?productid=081&source=labmate |
| Oct 05 2010 - Oct 06 2010 |
Effective Quality Assurance Auditing for FDA Regulated Industries |
King of Prussia, PA |
The need for quality assurance auditing has been recognized, and is required, by every active pharmaceutical ingredient (API)/bulk pharmaceutical chemical, medical device and finished pharmaceutical CGMP regulation published worldwide. Quality Assurance Auditing is a corner stone of ISO Standards-required Quality Systems, without which compliance to quality standards is impossible.
Experience reveals that many internal company audits and many external supplier/contractor audit programs are ineffective. This course provides the rationale, strategies, techniques and tips, on how to plan and perform effective quality assurance audits.
The course explores the politics, psychology and all the technical aspects of auditing, including discussions of their logistics, tools, and frequency. The course evaluates the talents and personnel characteristics required of a good auditor and those required of an excellent auditor.
The name of the game is effecting change. Determining operational deficiencies is only one aspect of an audit. The key issue is how to effect change to bring about compliance to company and legal standards. This course considers how to effect change and how to make audits a positive experience for the auditor and auditee. |
http://www.cfpie.com/showitem.aspx?productid=028&source=labmate |
| Oct 05 2010 - Oct 06 2010 |
The EU Clinical Trial Directive |
Dublin, Ireland |
This course focuses on understanding the requirements of the new EU Clinical Trial Directive and the issues inherent in any new regulatory process. The course covers all relevant topics associated with the Directive, the reasons behind its introduction and a review of methods for effective implementation.
Key topics to be discussed:
* The current regulatory situation in relation to clinical trials in the EU.
* The purpose of the new Clinical Trials Directive.
* Meeting the New Requirements for Chemical Authorization and Conduct
* Understanding the impact the Directive will have on running clinical trials
* An overview of key areas of the Directive:
- Regulatory approval/notification
- Ethical review
- Exemptions under the current arrangements
- Informed consent
- Good manufacturing practice
- Safety reporting
- Inspection
* Gain a detailed explanation of the key differences between ICH GCP and the new EU Directive |
http://www.cfpie.com/showitem.aspx?productid=030&source=labmate |
| Oct 06 2010 - Oct 07 2010 |
9th International Symposium on Scanning Probe Microscopy & Optical Tweezers in Life Sciences |
Berlin, Germany |
The event covers the applications of scanning probe microscopy (SPM) and optical tweezers technology to areas including biophysical, biochemical and medical research, stimulating fruitful discussions between the scientific communities of these complementary techniques. Leaders in the field together with novices are encouraged to learn from each other, discuss the presentations and share their experiences.
http://www.nanobioviews.net/spm-optical-tweezers.html |
info@nanobioviews.net |
| Oct 07 2010 - Oct 08 2010 |
Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products |
King of Prussia, PA |
Whether for biopharmaceutical or pharmaceutical applications, this course presents the technical basics that govern aseptic processing and provides practical advice for attendees to troubleshoot and manage their aseptic operations. Although, the course emphasizes industrial microbiology, various types of sterilization, and facility design fundamentals, these subjects are presented in the context of regulatory compliance, Good Manufacturing Practice, and FDA/international current thinking.
Please be aware that this course is designed to address aseptic filling common to biotech and pharmaceutical products. It does not address formulation development, cell culture, fermentation, preparative separations, or similar upstream or downstream processes. |
http://www.cfpie.com/showitem.aspx?productid=005&source=labmate |
| Oct 07 2010 - Oct 08 2010 |
European Filing & Registration Procedures |
Dublin, Ireland |
This course specifically focuses on agencies that control the regulatory process. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in the EU and individual European countries. Content will include descriptions of the methods by which regulators in the corresponding agencies process filings and registrations.
The current regulatory climate will be discussed in depth and numerous examples will be provided to illustrate effective filing techniques. Common issues which have caused difficulties for pharmaceutical firms will be discussed. Course content will explain how the EU interacts with national regulatory agencies and how personnel can best address the conflicts that sometimes arise.
This course will also be useful for sales or general management personnel who need an overview of the registration process within the EU. |
http://www.cfpie.com/showitem.aspx?productid=031&source=labmate |
| Oct 07 2010 - Oct 08 2010 |
How to Implement Risk Management Principles and Activities within a Quality Management System |
King of Prussia, PA |
Upon completion of this course, attendees will understand how to effectively meet the requirements of risk management for medical devices, pharmaceutical and biologics products and processes. Emphasis will be placed on the effective use of resources in a production and quality system environment by developing strategies based on risk.
The first day will cover the general context for risk management, required procedures and the discussion of the general ISO 14971, FDA, and GHTF requirements of risk management. The second day will discuss and apply several risk management techniques which will be covered as they relate to product and production processes. |
http://www.cfpie.com/showitem.aspx?productid=041&source=labmate |
| Oct 07 2010 - Oct 08 2010 |
Quality System Regulation for the Medical Device & Biotech Industries |
King of Prussia, PA |
This course will introduce you to the Quality System Regulation in the medical devices and biotech industries. Topics covered will include not only the legal requirements for QSR in the Federal Food, Drug, and Cosmetic Act but also how to develop practical applications in order to demonstrate compliance. The faculty consists of individuals with long and distinguished experience in the field.
Throughout this course, the fundamentals of FDA inspections commonly surface. There is special emphasis on discussing procedures and practices of this regulatory agency to help firms comprehend management aspects of FDA inspections. |
http://www.cfpie.com/showitem.aspx?productid=066&source=labmate |
| Oct 11 2010 - Oct 12 2010 |
FDA Inspections - What to Expect and How to Prepare |
King of Prussia, PA |
Personnel attending this interactive program will have an opportunity to learn how to prepare for an FDA inspection, what to expect during interaction with FDA officials and how to respond to FDA observations. Additionally this course is a good refresher for all personnel involved in the FDA inspection process and an opportunity to compare your internal audit system against what a leading internal audit expert believes is the best approach to implement. The course is provided in an informal atmosphere and an easily understood format.
The following are examples of some of the issues addressed during the course:
* What your organization can do to prepare for the inspection
* What information can the FDA request during an inspection
* Can a Warning Letter be issued immediately after an FDA inspection
* When can the FDA take action without issuing a Warning Letter
* What does the FDA look for during inspections
* How does the FDA classify a recall
* What are the timeframes for the U.S. DOJ's and FDA's handling of clear criminal fraud cases
* What type of documentation is required and what is the correct format
* What do the FDA's export regulations mean to your firm
* What types of cases does the FDA refer to the DOJ for prosecution
* When can the FDA suspend, deny or withdraw abbreviated new drug applications (ANDAs)
* How to respond to FDA actions
* Under what conditions can the FDA debar companies and individuals
* What to do after the FDA has taken action |
http://www.cfpie.com/showitem.aspx?productid=033&source=labmate |
| Oct 11 2010 - Oct 01 2010 |
How to Monitor Clinical Trials for GCP Compliance |
King of Prussia, PA |
This training course provides a solid understanding of GCP requirements and clinical quality assurance overviews for clinical trials. Attendees will gain experience in proven techniques for detecting, correcting and preventing clinical study deficiencies at domestic and international clinical sites. This course teaches participants how to ensure that their data and supporting documentation are completely accurate, factual and in the appropriate format for company and regulatory authorities. Included in the course work are practical examples and a roadmap for evaluating SOPs, consent forms, investigator brochures and source documents through presentation and interactive case studies. |
http://www.cfpie.com/showitem.aspx?productid=043&source=labmate |
| Oct 11 2010 - Oct 12 2010 |
Medical Devices - EU Directives, Guidance, CE Marking and ISO Standard Certifications |
Dublin, Ireland |
This is a two-day workshop focusing on understanding the requirements of the Medical Device Directives, their linkage to the EU Clinical Trial Directive and the requirements of CE Marking and ISO Certification on commercializing products. The course covers all relevant topics associated with the Directives and Guidance Documents, the reasons behind their introduction and a review of methods for effective implementation.
Key topics to be discussed include:
*
The current regulatory situation in relation to Medical Devices in the EU
*
The purpose of the Medical Device Directives
*
Meeting the New Requirements for Conformity Assessment by Product Type
*
Understanding the impact the Directive will have on developing and marketing new Medical Device products
*
An overview of key areas of the Directive
o Scope of application and definition
o Essential Requirements
o Medical Device Type & Process Path
o Medical Device Technical File
o Clinical Investigations
o Clinical Evaluations
o Notified Bodies
*
Gain a detailed understanding of all Guidance Documents available to assist in implementation of these directives |
http://www.cfpie.com/showitem.aspx?productid=092&source=labmate |
| Oct 12 2010 - Oct 13 2010 |
Marketing, Advertising and Promotion of Pharmaceuticals and Medical Devices |
King of Prussia, PA |
Upon completion of this course, participants will have an excellent understanding of the laws and policies affecting advertising, marketing and promotion, and the manner of their application in practice. Attendees will be better able to develop marketing and advertising programs and avoid issues which regulatory agencies continually review.
Regulatory affairs professionals and attorneys will receive training in the applicable laws, regulations and agency policies and gain practical knowledge of how to detect and analyze pitfalls in dealing with the review process. Participants will also gain an understanding of how third parties, such as the FDA, the FTC - and even the courts ? currently view advertising and marketing issues. An increased awareness of the disparate roles of various corporate departments in the development of advertising and promotion and strategies for their interaction/cooperation is also an important goal of the course. |
http://www.cfpie.com/showitem.aspx?productid=056&source=labmate |
| Oct 13 2010 - Oct 15 2010 |
Process Validation for Medical Devices |
King of Prussia, PA |
The guideline on ?General Principals of Process Validation? was issued in May, 1987, and subsequently, medical device companies have struggled with the principals of process validation. The FDA believes through careful design and validation of both the process and process controls, a manufacturer can establish a high degree of confidence that all manufactured units from successive lots will be acceptable. Successfully validating a process may reduce the dependence upon intensive in-process and finished product testing.
Due to the complexity of today's medical products, routine end-product testing alone is often not sufficient to assure product quality for several reasons. Some end-product tests have limited sensitivity. In some cases, destructive testing is required to show that the manufacturing process is adequate. In certain situations end-product testing does not reveal variations that may occur in the product which may impact safety and effectiveness.
Learn how the FDA has identified a risk-based approach as one of the driving principles of the current Good Manufacturing Procedures (cGMP) initiative, and how the FDA believes the use of risk management principles will enhance the Agency's inspection and enforcement program. |
http://www.cfpie.com/showitem.aspx?productid=089&source=labmate |
| Oct 13 2010 - Oct 15 2010 |
QA/QC Strategy for Biopharmaceuticals and Biologics |
King of Prussia, PA |
While there are considerable similarities between biologics/biopharmaceuticals and chemically-synthesized drug products, many of the QA/QC issues and challenges are significantly different. Biology-based drug products are more complex products, derived from potentially changing living sources that are highly susceptible to contamination with adventitious agents such as prions, viruses and mycoplasmas. Process-related impurities in biologic/biopharmaceutical products raise concern not only of potential toxicity but also of tumorigenicity and immunogenicity. Furthermore, unlike many chemically-synthesized drug products, the manufacturing process itself can impact both the potency and the immunogenicity of biologic/biopharmaceutical products.
This landscape for biologic and biopharmaceutical products, coupled with ongoing changes in regulations and expectations, makes it extremely important for a company to have an effective QA/QC risk management strategy for each stage of drug development, from Phase 1 clinical trials through market approval.
This course highlights the challenges and pressures facing QA/QC in today?s biologic and biopharmaceutical environment, and presents the strategic importance and value generated by QA/QC for their involvement in control of the manufacturing process, and testing and release of these products. QA/QC regulations and guidances from the U.S. FDA, EMEA and ICH are discussed in detail. |
http://www.cfpie.com/showitem.aspx?productid=065&source=labmate |
| Oct 13 2010 - Oct 14 2010 |
Detecting Fraud & Misconduct in Clinical Trials |
King of Prussia, PA |
This course provides a solid understanding of GCP requirements and clinical quality assurance in detecting fraud and misconduct in clinical trials. Attendees will gain experience in detecting, correcting and preventing clinical study misconduct and fraud at domestic and international clinical sites.
Additionally, attendees with learn how to ensure that their study conduct and supporting documentation is accurate and factual. The course will also address how to uncover misconduct, as well as, dealing with its consequences while identifying proactive solutions to prevent further problems. Included in the course work are practical examples and a roadmap for evaluating study conduct, source documents, case report forms and other study documentation through presentation and interactive case studies. |
http://www.cfpie.com/showitem.aspx?productid=117&source=labmate |
| Oct 14 2010 - Oct 15 2010 |
Pharmaceutical Production Batch Record Review |
King of Prussia, PA |
Efficient and effective batch record reviews provide pharmaceutical companies with two strategies. First, reviews are key to maintaining control of your firm?s operations, eliminating any guesswork and aiding in the resolution of atypical occurrences. Secondly, they enable a company to maintain and demonstrate a compliant posture - a sure way to avoid any quandary with the regulatory agencies.
This course is intended to take the mystery out of the batch record review process. The class examines the FDA and EU regulatory requirements for documentation and batch record reviews, explains the elements of the batch record review process, and clarifies the pathway to effective deviation investigations. Interactive sessions are included for identifying reviewer responsibilities, establishing good documentation practices, and writing procedures for the review process. Additionally, participants will be able to analyze their company?s compliance with these requirements and identify missing elements of the batch review process.
Ample time is provided to address specific problems and questions of individual participants. |
http://www.cfpie.com/showitem.aspx?productid=058&source=labmate |
| Oct 18 2010 - Oct 19 2010 |
Analytical Method Validation for Biologics, Biopharmaceuticals and Other Therapeutic Products |
King of Prussia, PA |
Complex processes yielding complex products such as biologics and biopharmaceuticals demand numerous, non-compendial, and sometimes complex, QC test methods to confirm manufacturing consistency and product quality. This course provides a comprehensive overview of the international regulatory authority requirements and expectations for test method validation of these assays. This course will prepare attendees with the knowledge and tools to plan and execute test method validation packages for the NDA, BLA and MAA market application dossiers, covering in-process, release and stability assays commonly used by QC in biologic and biopharmaceutical companies.
The course will cover validation of QC analytical test methods (e.g., electrophoretic, HPLC, peptide mapping, etc.), cell-based potency bioassays, immunochemical binding impurity assays and adventitious agent assays. |
http://www.cfpie.com/showitem.aspx?productid=096&source=labmate |
| Oct 18 2010 - Oct 19 2010 |
Introduction to Statistical Analysis of Laboratory Data |
King of Prussia, PA |
Basic Methods (Day One). This section of the course will detail the basic and intermediate statistical concepts that are essential for professionals in the field. The first day emphasizes the principles of descriptive and inferential statistical applications and focuses on actual study examples, problem solving and interpretation of results. Throughout the course the participants are encouraged to ask questions and discuss examples relevant to their own work.
Advanced Topics (Day Two). This section of the course will go beyond the basics and cover more complex issues in laboratory investigations with examples. Topics will include:
* Association studies including correlation and regression analysis with laboratory applications
* Analysis of robustness and ruggedness
* Method comparison using more accurate alternatives to correlate analysis and other pair-wise comparisons
* Outliers, limit of detection and limit of quantitation
* Statistical quality control for process stability and capability |
http://www.cfpie.com/showitem.aspx?productid=046&source=labmate |
| Oct 20 2010 - Oct 22 2010 |
Biostatistics for Non-Statisticians |
King of Prussia, PA |
Introductory Methods (2 Days). This part of the course will introduce and detail the basic and intermediate statistical concepts that are essential for professionals in a biological, public health or medical environment. The first day will emphasize the principles of descriptive and inferential statistical applications while the second day will focus on actual study examples, problem solving and interpretation of results. Throughout the course, participants are encouraged to ask questions and discuss examples relevant to their own work. The following include but are not limited to topic areas to be discussed.
* Basic statistical terminology needed to effectively communicate with and understand your statistical colleagues
* The statistical essentials required to initiate a research investigation
* Research questions in statistical terms
* Sample size considerations to insure accuracy of conclusions in clinical trials to determine treatment efficacy
* Discussion of statistical techniques to compare experimental approaches or treatment efficacy
Advanced Topics (3rd Day). This section of the course will cover more complex issues in research investigations and clinical trials. Topics will include:
* Association studies including correlation and regression analysis with clinical applications
* Examination of Phase I, II and III clinical trials analysis
* Survival analysis and discussion of techniques in bioequivalence and biotherapeutic studies
* Gaining information from multiple studies by meta-analysis |
http://www.cfpie.com/showitem.aspx?productid=010&source=labmate |
| Oct 20 2010 - Oct 22 2010 |
CMC Regulatory Compliance for Biopharmaceuticals and Biologics |
King of Prussia, PA |
With the rapid development and constantly changing Chemistry, Manufacturing & Controls (CMC) landscape, it is more important than ever for a company to have an effective strategy to achieve CMC regulatory compliance.
At each stage of drug development, from Phase 1 through market approval, one basic question needs to be addressed: ?What is absolutely necessary, from a CMC regulatory compliance perspective, to be successful in getting our biopharmaceutical/biologic through clinical trials and into the market?? CMC regulatory compliance deficiencies have resulted in clinical holds and delays in obtaining market approval. CMC shortfalls in marketed products have also resulted in FDA Warning Letters and product recalls. Insights and practical suggestions on how to develop and manage a clinical phase-dependent CMC regulatory compliance strategy for biopharmaceuticals and biologics are offered in this course.
This course also includes a discussion on preparing CMC sections for a market application dossier using the Common Technical Document (CTD) formatted Modules 2.3 and 3 for biopharmaceuticals and biologics. CMC compliance regulations and guidances from the U.S. FDA, EMEA and ICH are discussed. |
http://www.cfpie.com/showitem.aspx?productid=017&source=labmate |
| Oct 21 2010 - Oct 22 2010 |
Auditing and Qualifying Suppliers and Vendors |
Berlin, Germany |
Regulatory agencies hold firms responsible for delivering high quality products that meet all established requirements and specifications. Suppliers and vendors play a key role in accomplishing these mandates and it is the firm?s responsibility to make sure vendors/suppliers are meeting specifications for the supplied materials, components, equipment and/or services.
For many years, industry has implemented procedures for selection, approval and qualification of suppliers and vendors. However, in many cases these protocols were not being implemented effectively or formally documented. Making these programs part of a risk-based quality systems approach that the FDA and other regulatory agencies have come to expect from industry is critical. The course will include a process for selection, audit, approval and qualification of vendors/suppliers based on the material/equipment/service being delivered. These decisions must be documented and must be based on the impact (risk) to the final product.
Initially, the course will discuss the regulatory expectations and other industrial references/standards that will impact your system and will include the general requirements of a vendor/supplier (outsourcing) control program followed by specific requirements for different types of supplied materials/equipment/services. During these sections, attendees will establish the documentation requirements, applicable audits and the impact of the quality agreement/contract details.
In conclusion, participants will learn the maintenance aspects of such a program including handling of non-conformances, additional audits and change control. During the course, several interactive exercises will be included to provide opportunities for discussion and sharing of experiences. |
http://www.cfpie.com/showitem.aspx?productid=004&source=labmate |
| Oct 21 2010 - Oct 22 2010 |
Essentials of Program, Project & Portfolio Management in Bio/Pharmaceutical Discovery |
King of Prussia, PA |
This course provides a comprehensive overview and in-depth analysis of project leadership and portfolio management in the discovery phases of R&D in biotech, biopharmaceutical and pharmaceutical companies. The course presents an overview of how project leadership and portfolio management serve R&D management needs across industries as defined by the Project Management Institute. This general model is then compared with current practice in Biopharmaceutical R&D. Both project leaders and portfolio managers will learn about tools that support their work, typical challenges, and how to optimize their own performance. Project leaders will learn how to enhance the performance of their team. Portfolio managers will learn how to optimize the portfolio management function in their company.
Each session features attendee participation and experience sharing, so that participants can learn from each other's experience as well as from the instructor.
Attendees will receive a bibliography with informational and "how-to" books, as well as valuable on-line references. |
http://www.cfpie.com/showitem.aspx?productid=123&source=labmate |
| Oct 25 2010 - Oct 26 2010 |
Best Practices for an Effective Cleaning Validation Program |
Berlin, Germany |
This course provides practical guidance on cleaning validation regulatory compliance, in conjunction with, risk-based, reasonable and informed decision making and activity planning. The program will describe the requirements for establishing an effective cleaning validation program, including the development of a general policy, a ?Cleaning Validation Master Plan? and the appropriate documentation for each study to be performed. In addition, requirements for maintenance of the validated status will be reviewed. Regulatory requirements and the latest industry practices will also be included in the discussion.
Cleaning validation examples from pharmaceutical, biologic and biopharmaceutical manufacturing processes will be included.
Additional benefits of this class include:
* All participants receive a Resource CD with templates for Cleaning Validation Plans, protocols and additional references
* Learn not just from the director, but tap into the knowledge of your peers: Participants will have the opportunity to discuss their challenges and problems
* Participants will also have the opportunity for one-on-one consulting with the course director during course breaks and in the evenings. The course director has over 24 years of industry experience, and over 14 years of consulting experience |
http://www.cfpie.com/showitem.aspx?productid=007&source=labmate |
| Oct 25 2010 - Oct 26 2010 |
Design Control for Medical Device Professionals |
King of Prussia, PA |
This continually updated course covers current FDA regulatory compliance with respect to developing medical devices. A focus will be placed on basic regulation and the FDA's supplemental guidelines.
Among the topics to be discussed are: context of design control within the overall quality system and regulation, design control procedures, forms, records, safety/risk management strategies, documentation strategies, manufacturing transfer strategies, and strategies for integrating general quality system procedures into design control. |
http://www.cfpie.com/showitem.aspx?productid=024&source=labmate |
| Oct 25 2010 - Oct 26 2010 |
Effective Document Management for the Pharmaceutical, Biotech & Medical Device Industries |
King of Prussia, PA |
If you didn?t write it down, it didn?t happen! This is the position of the FDA and most regulatory agencies internationally. Good documentation is vital for doing business in the regulated world from discovery through marketplace. It is also important for due diligence and regulatory inspections, and is necessary for the success of your products and services. While the regulations tell you what you must do, they don?t tell you how. Based on industry best practices, this course clarifies how to refine your existing system, create a new one, or prepare to transition from a manual system to electronic controls.
This course also addresses what documents you need to control, what documentation you need to support your actual system and how to keep your documents current and compliant. |
http://www.cfpie.com/showitem.aspx?productid=027&source=labmate |
| Oct 26 2010 - Oct 27 2010 |
Pediatric Clinical Trial Design - Ethics, Management and Regulatory Requirements |
King of Prussia, PA |
Medicines and devices for children are an active and rapidly growing area of pharmaceutical research and development in response to requirements by FDA in 1997 and EMEA in 2007. Increased pressure to conduct trials in children can be daunting when faced with practical, legal and clinical considerations found only in pediatric trials. Successfully implementing regulations and ethical standards into study conduct requires a comprehensive understanding of the unique concerns raised by ethics committees, investigators and parents.
This course will review a process for closing the gap between regulatory requirements and study execution. Participants will acquire strategies for risk management in the areas of regulatory compliance, protocol execution and participant safety. Guidance documents important to pediatric research will be reviewed within the context of case studies from completed programs. Participants will be given an opportunity to share their experience during working sessions on protocol design and ethical issues.
In addition, there will be ample time to address specific problems and questions of individual participants. |
http://www.cfpie.com/showitem.aspx?productid=115&source=labmate |
| Oct 27 2010 - Oct 28 2010 |
Design Validation, Verification, and Risk Analysis for Medical Device Professionals |
King of Prussia, PA |
This course covers current FDA regulatory compliance with respect to developing medical devices. Focus will be placed on relevant aspects of FDA regulation to V&V and Risk Analysis and the FDA's supplemental guidelines. An ISO perspective is offered to compliment the FDA view.
Among the topics to be discussed are: Context of V&V and Risk Analysis within the overall quality system and regulation, V&V and Risk analysis procedures, V&V methodologies, V&V strategies, types of risk analysis, risk mitigation, and methods to determine probability and severity for Risk analysis. |
http://www.cfpie.com/showitem.aspx?productid=118&source=labmate |
| Oct 27 2010 - Oct 28 2010 |
Process Validation for Drugs and Biologics |
Berlin, Germany |
Process validation is not a curse invented by regulators and pushed onto a company by QA staff. Instead, it is a legal requirement in the pharmaceutical industry. The concept of process validation is recognition that quality cannot be tested into the product and must be designed into the process/product to reduce the risk of non-conformances during/after manufacturing.
This course provides practical guidance on compliance with the requirements of process validation that lead to risk-based, reasonable and supportable informed decisions. Compliance with the requirement for process validation must go hand in hand with sound science for the proper evolution of critical processes.
The course includes process validation examples from pharmaceutical, biologic and biopharmaceutical manufacturing processes. This includes the manufacturing of the API and the finished drug products. |
http://www.cfpie.com/showitem.aspx?productid=049&source=labmate |
| Oct 28 2010 - Oct 29 2010 |
FDA Inspections of Clinical Data Systems |
King of Prussia, PA |
This course focuses on preparation for FDA systems inspections whether establishing a new program or seeking improvements in an ongoing quality initiative. The course provides practical information for improving presentation and substance of Clinical Data Systems documentation in anticipation of a FDA Inspection. In addition, the course will address critical issues and potential observations resulting from a Clinical Data Systems audit.
The attendee will be able to develop action plans based on course material to improve the company's compliance position for an inspection. The executed plans will also strengthen evidence that the Clinical Data System performs to business and quality expectations.
Topics include the following: Inspection Fundamentals; Computer Validation and Part 11 Inspection Concerns; Assessing Standard Operating Procedures; Assessing System Documentation; Preparing for the Inspection and Maintaining Compliance. |
http://www.cfpie.com/showitem.aspx?productid=034&source=labmate |
| Oct 28 2010 - Oct 29 2010 |
Introduction to Effective Medical Writing |
King of Prussia, PA |
High-quality medical writing, which has a multi-million dollar impact on a company?s financial performance, can prevent the need for additional clinical trials which are often required because of unclear communication and poorly written documents. Good medical writing can lead to optimal product labeling, allowing successful product promotions and maximization of advertising claims.
Well written submission documentation can decrease the length of the product marketing approval process and increase the amount of time a product can be sold under patent protection. This course provides an overview of how to present product information clearly and concisely for the targeted audience. Hands-on exercises reinforce the course content. |
http://www.cfpie.com/showitem.aspx?productid=047&source=labmate |
November 2010 |
| Date |
Event Title |
Location |
Details |
Contact |
| Nov 01 2010 - Nov 02 2010 |
Project Management for Phase 1 & 2 Clinical Trials |
King of Prussia, PA |
Efficient and effective management of Phase 1 and 2 clinical trials can significantly impact the time, scope and budget for the development of a drug or device. Project managers must understand the development process and the key aspects of Phase 1 and 2 in order to act, react and adapt to change when the program moves forward and new data is acquired. Successful completion of Phase 1 and Phase 2 clinical trials are key project milestones. This course focuses on the best practices for developing and managing these trials within GCP guidelines and FDA regulations.
The course will discuss the challenges associated with clinical trials run outside the United States and identify key differences, common pitfalls, and cultural differences. Guidance for the how-to as well as problem-solving for specific situations such as slow enrollment, high screen failures, or issues with data quality will be provided. The course is interactive and designed to allow for the exchange of ideas between peers in addition to learning from the instructor. |
http://www.cfpie.com/showitem.aspx?productid=100&source=labmate |
| Nov 02 2010 - Nov 03 2010 |
Preparation of FDA Submissions (INDs, NDAs, BLAs, ANDAs, Post-Approval Supplements) and Communicating with the FDA |
Berlin, Germany |
This course will give participants the background and history of the US Food and Drug Administration (FDA) as a basis for the strategic planning of submitting INDs, NDAs, BLAs, ANDAs, and post-approval supplements. Each item of these submissions will be individualized, analyzed, and discussed in conjunction with their importance in relation to FDA regulations and guidances. Each item will be detailed as to how to best present data for successful FDA approvals.
Course content will include preparation for FDA meetings and the nuances of pharmaceutical industry interaction with the FDA. Chemistry Manufacturing and Controls (CMC), Nonclinical and Clinical areas will be covered. The Common Technical Document (CTD) formatting will also be discussed. |
http://www.cfpie.com/showitem.aspx?productid=085&source=labmate |
| Nov 02 2010 - Nov 03 2010 |
Selecting and Managing CRO's |
Berlin, Germany |
This course will provide the attendees with all the specific methodology and management techniques to successfully outsource pharmaceutical programs that are completed on time, within budget, and most importantly completed with a high level of quality and performance. Participants will gain an in depth perspective focused on the components of performance and quality based management of drug development. Participants will learn how the current external and internal forces are shaping the way projects will need to be delivered to be competitive and cost efficient given the state of the industry.
Specific attention will be given to defining meaningful Key Performance Indicators (KPI?s), implementing those indicators into the process, and gathering/analyzing data to proactively deliver quality studies.
Pharmaceutical and Biotechnology research managers and their counterparts in the CRO industry will gain a thorough understanding of how to work together through implementing outsourcing scorecards to achieve successful outsourcing programs. |
http://www.cfpie.com/showitem.aspx?productid=086&source=labmate |
| Nov 03 2010 - Nov 05 2010 |
Optimization of Drug-Like Properties in Drug Discovery ? Assessment And Structure Modification Strategies |
King of Prussia, PA |
The content of this course will assist pharmaceutical, biotechnology, and CRO researchers and managers in understanding the challenges associated with developing systemically active and safe drug candidates. Emphasis is placed on the design of molecules possessing those structural characteristics responsible for optimal drug-like properties. Each of the ADME requirements will be addressed in terms of physical properties (e.g. lipophilicity, polarity, ionization), and strategies to assess and optimize each parameter will be discussed. Specific methods, protocols, and applications as well as the latest developments in the field will be highlighted. |
http://www.cfpie.com/showitem.aspx?productid=022&source=labmate |
| Nov 03 2010 - Nov 05 2010 |
Spectroscopic Method Development for the Pharmaceutical and Biotech Industries |
King of Prussia, PA |
Spectroscopic techniques are used widely in the pharmaceutical and biotech industries for qualitative analysis, quantitative analysis, and identity testing. The emphasis in this course will be on teaching you a process to follow to develop spectroscopic methods properly. This includes learning how spectrometers work, understanding the information they give, what they can and cannot do, and finding and eliminating sources of error. The course begins with an introduction to spectroscopy including quantifying sources of error in spectroscopic measurements, a brief introduction to the statistics needed to perform this work, and the basics of spectroscopic calibration.
A unique emphasis of the course will be the proper development of qualitative and identity testing methods. Too many people give these methods short shrift?at their peril. It is just as important to know what goes into a drug as how much of it goes in. You will learn a process for properly developing qualitative methods. This is based on an understanding of relevant spectroscopic techniques, what information they give, how to properly use that information, and finding and minimizing error sources. You will learn about powerful new algorithms that automate and objectify qualitative methods reducing their subjectivity and increasing their reliability.
Quantitative spectroscopic techniques are used to measure concentrations and properties of unknown samples. After a thorough introduction to the science behind quantitative spectroscopy, the process to follow to achieve robust and accurate calibrations is taught. This is based on an understanding of the assumptions behind quantitative analysis, knowing the instrumentation, and finding, measuring, and minimizing error sources. This process is then applied to quantifying single and multiple chemical species, including molecules and elements, in unknown samples. The course concludes with how to implement, maintain, and troubleshoot spectroscopic calibrations. |
http://www.cfpie.com/showitem.aspx?productid=125&source=labmate |
| Nov 03 2010 - Nov 04 2010 |
Project Management for the Phase 3 and LCM (Life Cycle Management) of the Drug Development Process |
King of Prussia, PA |
The course provides a thorough understanding of the activities involved during Phase 3 and 4 of Drug Development. The intent is to provide detailed knowledge of project management practices, skills and tools that will make the difference between a successful clinical trial and one that does not meet its goals. The course will focus on issues that impact late stage R&D, including product launch and commercialization. By the end of the course, participants should be able to:
* Understand the overall drug development process and the unique aspects of Phase 3, 4 and Life Cycle Management
* Apply project management best practices to clinical trials
* Manage a development project team and recognize team needs and leadership skills required for this stage of the drug development process
* Understand GCP guidelines, FDA regulations and ICH guidelines
* Understand and manage the challenges of clinical trials outside the USA
* Manage, monitor and control clinical trial timelines and budgets
* Identify and manage outsourcing aspects of the project
* Select the best drug delivery system and incorporate into the project plan
* Develop and maintain partnerships with CRO?s and other support organizations
* Actively manage project risks and opportunities
* Manage adverse event reporting and protocol deviations
* Prevent and manage fraud and study misconduct |
http://www.cfpie.com/showitem.aspx?productid=101&source=labmate |
| Nov 04 2010 - Nov 05 2010 |
Drug Master Files (DMFs) - Understanding and Meeting Your Regulatory and Processing Responsibilities |
Berlin, Germany |
This course provides attendees with an understanding of the role DMFs play in the FDA's regulatory approval process for drugs and biologics. The course will take participants through a step-by-step process of DMF preparation and explain the types of information essential for any Drug Master File. Additionally, this course explains why "one size does not fit all" and emphasizes the importance of customizing DMFs in both preparation and maintenance for particular products and businesses.
The course offers methodologies and techniques on:
* Who really needs a DMF and why
* The various types of DMFs - which is best for your products
* The relationship between DMFs and drug and biologics applications
* The symbiotic relationship between DMFs and current Good Manufacturing Practices (cGMPs)
* Common DMF errors - how to avoid them
* How to deal with deficiency letters and their origins
* Effective change control strategies
* Ramifications of inadequate preparation and/or maintenance and recent enforcement actions and inspectional trends |
http://www.cfpie.com/showitem.aspx?productid=026&source=labmate |
| Nov 04 2010 - Nov 05 2010 |
Effective Laboratory Safety Management |
King of Prussia, PA |
This course focuses on creation and implementation of a health and safety program and addresses key topics including measuring OH&S performance and setting up a functional system. Attendees will also be introduced to the concept of the internal responsibility system and discuss how that relates to the new ANSI Z-10-2005 standard (American National Standard for Occupational Health and Safety Management Systems).
Additionally, the course will address some of the ?people aspects? of safety management, including:
* Demonstrating the costs and benefits of safety initiatives
* Encouraging compliance with the program by both new and long-term employees (dealing with perception and personalities)
* Managing change towards a ?safety culture?
* Effective health and safety committees
* Collecting and providing information and statistics that matter
The course consists of oral presentation, problem solving sessions, group discussions, and case studies. Participants are encouraged to raise their own workplace issues with the expectation that they will bring back practical solutions and approaches to solve current concerns. |
http://www.cfpie.com/showitem.aspx?productid=088&source=labmate |
| Nov 04 2010 - Nov 05 2010 |
Stability Programs for Product Shelf Life - From Development to Approval |
Berlin, Germany |
This continually updated course covers current FDA regulatory requirements and ICH guidelines as applied to designing stability programs from the early stages of product development all the way to approval. Among the topics to be discussed will be: identifying FDA?s regulations and ICH guidelines for stability testing, writing study protocols and SOPs, designing and validating stability indicating analytical test methods, establishing Successful Stability Data Management Systems, conducting and documenting OOS results and deviations, and preparing for an FDA inspection of stability program. |
http://www.cfpie.com/showitem.aspx?productid=072&source=labmate |
| Nov 08 2010 - Nov 09 2010 |
Cleanroom Microbiology for the Non-Microbiologist |
King of Prussia, PA |
This course provides practical information on contamination control and cleanroom management. Extensive guidance is presented for the critical daily aseptic maintenance and housekeeping functions necessary to maintain the cleanliness levels required.
Topics to be discussed include:
* General product requirements
* Special requirements for sterile products
* Particles, microorganisms and pyrogens
* Review of terminal sterilization process
* Complexity of aseptic processing approaches
* Methods for proper aseptic surface contamination control
* Repair and maintenance technologies & how to start up a new facility |
http://www.cfpie.com/showitem.aspx?productid=016&source=labmate |
| Nov 10 2010 - Nov 12 2010 |
The CTD/eCTD: Building the Marketing Application throughout Clinical Development |
Dublin, Ireland |
The guidance on marketing applications for drugs and biologics, known as the Common Technical Document (CTD), was finalized by the International Conference on Harmonization (ICH) in 2003. Today the CTD format is mandatory for paper-based marketing applications in Europe, Japan, Canada, and other regions, and is highly recommended by FDA.
The eCTD format has become mandatory in key regions for electronic submissions. Since January 2010, the European Medicines Agency has required all applications in the centralized procedure use the eCTD format. Since January 2008 FDA CDER has required all electronic submissions be in the eCTD format. FDA CBER requires the eCTD format for priority review and rolling submissions. This course will not only address the content and format of each module and sub-sections of the CTD, but will also demonstrate how the CTD/eCTD can be built throughout development starting with the IND.
This course is designed to identify and review applicable regulatory guidelines (U.S., EU, ICH, and other regional guidances), providing information on the content and preparation of the CTD, and will address specifications and granularity for electronic submissions (eCTD). The course discusses tips for efficient preparation of the CTD with submission-ready reports that can be written early in development and inserted or expanded for marketing applications. The use of CTD mapping and templates to facilitate gap analysis, project management, CMC strategy, and life cycle management will also be discussed in interactive sessions. Case studies will be presented throughout the course to encourage discussions. |
http://www.cfpie.com/showitem.aspx?productid=078&source=labmate |
| Nov 10 2010 - Nov 12 2010 |
The Drug Development Process ? From Discovery to Commercialization |
King of Prussia, PA |
The drug development process involves a series of lengthy steps that determine the degree of success for every drug brought to the market. Decisions made throughout the process affect every aspect of future development and impact heavily on commercialization strategies.
Included in the course content is an overview of the regulatory and pre-marketing steps that occur to ensure a successful launch. The course also covers sales planning and the commercialization decisions that affect the development of the drug. |
http://www.cfpie.com/showitem.aspx?productid=025&source=labmate |
| Nov 10 2010 - Nov 11 2010 |
Sterilization Procedures: Technology, Equipment & Validation |
King of Prussia, PA |
The course provides a basic but comprehensive presentation of sterilization procedures as they are now used in the pharmaceutical industry. The content of the course emphasizes the practical application of present-day basic scientific knowledge to the destruction of microbials, to the manufacture of sterile products, and to validation of the sterilization procedures used. After you complete this course you will be able to understand how and why specific sterilization methods are used in particular applications, how the methods are validated, and the strengths and weaknesses of different sterilization methods. You will also be presented with the trends in regulatory thinking applied to aseptic processes and in possible near-term future technological developments in sterilization methods and in microbial monitoring techniques. |
http://www.cfpie.com/showitem.aspx?productid=075&source=labmate |
| Nov 10 2010 - Nov 12 2010 |
27th LC/MS Montreux Symposium |
Montreux, Switzerland |
Symposium on LC/MS and all related hyphenated technologies including important aspects of the application challenges such as sample pretreatment, separation technologies and novel software/bioinformatics approaches. |
http://www.lcms-montreux.com |
| Nov 11 2010 - Nov 12 2010 |
Preparing the CMC Section for NDAs/CTDs/INDs |
King of Prussia, PA |
This course includes an overview of the International Conference on Harmonization (ICH) process and the organization of the CTD, detailed information and discussions related to each element required in the drug substance and drug product sections of NDAs and INDs. The course will emphasize the requirements related to drug substance starting materials, drug substance and drug product specifications, impurities, stability, and pharmaceutical development reports. It will also discuss the use of Drug Master Files (DMF) and preparation of the CTD Quality Overall Summary (Module 2). |
http://www.cfpie.com/showitem.aspx?productid=061&source=labmate |
| Nov 15 2010 - Nov 17 2010 |
Good Clinical Practices (GCP) |
King of Prussia, PA |
Upon completion of this course, each participant will have a thorough understanding of GCPs dictated by FDA and ICH Requirements for Sponsors, Monitors, and Investigators. In addition, the significance of these regulations will be correlated to protocol and case report form development for all phases of clinical research. Information regarding in-field and in-house auditing (i.e., Quality Assurance (QA) procedures compared to FDAs Bio-monitoring system) will be presented. Investigational Review Boards (IRBs) and Informed Consent (IC) as required by the FDA and ICH regulations are discussed in detail and are compared with GCP and ICH regulations. |
http://www.cfpie.com/showitem.aspx?productid=039&source=labmate |
| Nov 15 2010 - Nov 16 2010 |
Latin America - Understanding Regulatory Compliance Requirements |
King of Prussia, PA |
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Latin America. The primary countries covered will include: Argentina, Brazil, Chile, Costa Rica, Dominican Republic, Mexico, Panama, Peru and Venezuela. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Latin America. Content will include descriptions of the methods by which regulators in the corresponding agencies process filings and registrations and what is expected in the authorization and dossier maintenance of licensed products.
The current regulatory climate in Latin America is discussed in detail and several examples will be provided to illustrate effective compliance procedures and techniques. Common issues that have caused difficulties for Life Sciences firms in the region are outlined. Course content will explain how Latin America interacts with and utilizes ICH standards and how they relate with other national regulatory agencies. Additionally, participants will learn how personnel can best address the conflicts that arise and the best approach for resolution. |
http://www.cfpie.com/showitem.aspx?productid=055&source=labmate |
| Nov 16 2010 - Nov 17 2010 |
Pharmaceutical Water Systems: Contemporary Technology & Compliance |
King of Prussia, PA |
This course provides an interactive mix of lectures, workshops and discussions intended to highlight basic principles and technologies and how these are applied in practice to pharmaceutical water systems. The benefits from applying the principles discussed during the course will include:
* Minimize time spent in troubleshooting deviations and failures
* Set appropriate alert and action limits to avoid costly batch contamination
* Avoid regulatory agency?s observations and compliance issues and reduce inspection frequencies by building a history of compliance
The course is intended to raise practical understanding and awareness for water system owners and managers, QA managers, regulatory compliance staff, microbiologists, engineers, validation specialists and operators. |
http://www.cfpie.com/showitem.aspx?productid=093&source=labmate |
| Nov 17 2010 - Nov 18 2010 |
Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences |
King of Prussia, PA |
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Japan. Content will also include descriptions of the methods by which regulators in the corresponding agencies process filings and registrations and what is expected in the authorization and dossier maintenance of licensed products.
The current regulatory climate will be discussed in depth and several examples will be provided to illustrate effective compliance procedures and techniques. Common issues which have caused difficulties for Life Sciences firms will also be discussed. Course content will also explain how Japan interacts with and utilizes ICH standards and how they relate with other national regulatory agencies. The course will also discuss how personnel can best address the conflicts that sometimes arise and the approach that can best be taken for resolution.
This course will also be useful for sales or general management personnel who need an overview of the Regulatory Compliance requirements within Japan and how best to consider the country into one?s Business Strategy. |
http://www.cfpie.com/showitem.aspx?productid=053&source=labmate |
| Nov 17 2010 - Nov 20 2010 |
Medica |
Germany |
The worlds largest medical trade fair |
http://www.medica-tradefair.com/ |
| Nov 18 2010 - Nov 19 2010 |
Effective Risk-Based Applications of Drug cGMPs and Validation Requirements for Cosmetics and OTC Drug Products |
King of Prussia, PA |
This course provides the tools for risk-based implementation and continuous compliance with drug cGMPs for OTC drug product manufacturers, including cosmetic manufacturers that also produce OTC drug products. The course also covers regulatory expectations as contained in U.S. and International guidelines. This training prepares attendees to assess their current compliance status, develop strategies and plans for remediation of identified gaps and execute a plan to achieve compliance by initially addressing higher risk items within a reasonable time frame.
Attendees are given the opportunity to apply what they have learned during two workshops.
In addition, ample time will be provided to address specific problems and questions of individual participants. |
http://www.cfpie.com/showitem.aspx?productid=037&source=labmate |
| Nov 30 2010 - Dec 01 2010 |
Selecting and Managing CRO's |
King of Prussia, PA |
This course will provide the attendees with all the specific methodology and management techniques to successfully outsource pharmaceutical programs that are completed on time, within budget, and most importantly completed with a high level of quality and performance. Participants will gain an in depth perspective focused on the components of performance and quality based management of drug development. Participants will learn how the current external and internal forces are shaping the way projects will need to be delivered to be competitive and cost efficient given the state of the industry.
Specific attention will be given to defining meaningful Key Performance Indicators (KPI?s), implementing those indicators into the process, and gathering/analyzing data to proactively deliver quality studies.
Pharmaceutical and Biotechnology research managers and their counterparts in the CRO industry will gain a thorough understanding of how to work together through implementing outsourcing scorecards to achieve successful outsourcing programs. |
http://www.cfpie.com/showitem.aspx?productid=086&source=labmate |
December 2010 |
| Date |
Event Title |
Location |
Details |
Contact |
| Dec 01 2010 - Dec 03 2010 |
Good Manufacturing Practices |
Costa Mesa, CA |
Good Manufacturing Practice regulations (cGMPs) are used by pharmaceutical, medical device and food manufacturers as they produce and test products that people use (Drug cGMPs also apply to the veterinary drugs). In the United States (U.S.) the Food and Drug Administration (FDA) has issued these regulations as the minimum requirements. This course explores the regulations through which the Federal government controls the drug, cosmetics and diagnostic industries. Major emphasis is placed on understanding the need for and the intent of regulations and developing mechanisms for implementation and compliance.
This course is intended to give participants an introduction to cGMP regulations and their application to laboratory studies and manufacturing processes. It will also provide participants with an understanding of terminology and the role GMPs play in assuring their validity. Those attending will also get an understanding of the needs for thorough and comprehensive training and documentation.
Additionally, this course introduces students to the principles of GLP/GMP in the pharmaceutical and associated industries with the emphasis on the necessary procedures and documentation required to achieve full compliance. |
http://www.cfpie.com/showitem.aspx?productid=113&source=labmate |
| Dec 01 2010 - Dec 03 2010 |
Technical Writing for Pharmaceutical, Medical Device and Biotech Industries |
King of Prussia, PA |
Course notes and interactive exercises address how to write effective correspondence and reports in support of the company?s activities. You will learn how to organize and deliver information for the intended audience. You will learn how to write clear and readable documents, and how to revise and refine your own and others? writing. The course provides an overview of sound grammatical conventions, addresses problematic areas of the English language, and affords opportunities to address specific language issues. |
http://www.cfpie.com/showitem.aspx?productid=077&source=labmate |
| Dec 02 2010 - Dec 03 2010 |
Clinical Trial Design for Medical Devices |
Costa Mesa, CA |
Clinical trials design studies for medical devices are an integral part of the pre-market approval process. Keeping abreast of new scientific developments related to advances in applied clinical research is essential for successful product development. This course offers an opportunity for chemists, biologists, industrial engineers, and healthcare professionals to gain an in-depth understanding of the regulatory process for medical device applications, as well as, the global regulatory framework as it relates to the new medical device market. |
http://www.cfpie.com/showitem.aspx?productid=014&source=labmate |
| Dec 02 2010 - Dec 03 2010 |
Drug Master Files (DMFs) - Understanding and Meeting Your Regulatory and Processing Responsibilities |
King of Prussia, PA |
This course provides attendees with an understanding of the role DMFs play in the FDA's regulatory approval process for drugs and biologics. The course will take participants through a step-by-step process of DMF preparation and explain the types of information essential for any Drug Master File. Additionally, this course explains why "one size does not fit all" and emphasizes the importance of customizing DMFs in both preparation and maintenance for particular products and businesses.
The course offers methodologies and techniques on:
* Who really needs a DMF and why
* The various types of DMFs - which is best for your products
* The relationship between DMFs and drug and biologics applications
* The symbiotic relationship between DMFs and current Good Manufacturing Practices (cGMPs)
* Common DMF errors - how to avoid them
* How to deal with deficiency letters and their origins
* Effective change control strategies
* Ramifications of inadequate preparation and/or maintenance and recent enforcement actions and inspectional trends |
http://www.cfpie.com/showitem.aspx?productid=026&source=labmate |
| Dec 02 2010 - Dec 03 2010 |
Preparation of FDA Submissions (INDs, NDAs, BLAs, ANDAs, Post-Approval Supplements) and Communicating with the FDA |
Costa Mesa, CA |
This course will give participants the background and history of the US Food and Drug Administration (FDA) as a basis for the strategic planning of submitting INDs, NDAs, BLAs, ANDAs, and post-approval supplements. Each item of these submissions will be individualized, analyzed, and discussed in conjunction with their importance in relation to FDA regulations and guidances. Each item will be detailed as to how to best present data for successful FDA approvals.
Course content will include preparation for FDA meetings and the nuances of pharmaceutical industry interaction with the FDA. Chemistry Manufacturing and Controls (CMC), Nonclinical and Clinical areas will be covered. The Common Technical Document (CTD) formatting will also be discussed. |
http://www.cfpie.com/showitem.aspx?productid=085&source=labmate |
| Dec 06 2010 - Dec 08 2010 |
cGMP Quality Principles for Pharmaceuticals, Biopharmaceuticals, Biologics and Medical Devices |
King of Prussia, PA |
This course will provide the participant knowledge of current GMPs, how they are applied in the Bio/Pharmaceutical market today, and how they will be enforced in the future.
Topics included are:
* Impact of facility and equipment design on GMP compliance
* Risk management approach to compliance
* Vendors
* Commissioning, Qualification and Validation ? Which one to use
* Problem resolution
* Part 11 in production and the laboratory
A comparison between 21 CFR 210/211, 600, and 820 as well as ICH guidelines will be made as they affect combination products, normal Bio/Pharmaceuticals, and Medical Devices. Current ?hot? topics and examples of recent warning letters will also be discussed and evaluated. |
http://www.cfpie.com/showitem.aspx?productid=095&source=labmate |
| Dec 06 2010 - Dec 07 2010 |
Stability Programs for Product Shelf Life - From Development to Approval |
Costa Mesa, CA |
This continually updated course covers current FDA regulatory requirements and ICH guidelines as applied to designing stability programs from the early stages of product development all the way to approval. Among the topics to be discussed will be: identifying FDA?s regulations and ICH guidelines for stability testing, writing study protocols and SOPs, designing and validating stability indicating analytical test methods, establishing Successful Stability Data Management Systems, conducting and documenting OOS results and deviations, and preparing for an FDA inspection of stability program. |
http://www.cfpie.com/showitem.aspx?productid=072&source=labmate |
| Dec 08 2010 - Dec 10 2010 |
Root Cause Analysis for CAPA |
King of Prussia, PA |
The primary objective of this course is to develop an understanding of the principles and techniques involved in the practice of Root Cause Analysis. Emphasis is placed on the practical aspects of how to perform an analysis. In addition, this course will provide effective methods which can be used with a Corrective Action system to helps you and your team to ensure costly issues are resolved quickly and do not get dropped through the cracks.
The course will provide attendees with a system to categorize all types of issues, assign responsibility and track team activities to resolve important issues.
Attendees will also learn advanced skills in root cause analysis, problem prevention, and continuous improvement. Included will be the identification of the characteristics and changes that have contributed to simple and complex problems and how to fix them, as well as, working with the tools and templates to capture all needed data to comply with CAPA reports. |
http://www.cfpie.com/showitem.aspx?productid=069&source=labmate |
| Dec 08 2010 - Dec 10 2010 |
The CTD/eCTD: Building the Marketing Application throughout Clinical Development |
Costa Mesa, CA |
The guidance on marketing applications for drugs and biologics, known as the Common Technical Document (CTD), was finalized by the International Conference on Harmonization (ICH) in 2003. Today the CTD format is mandatory for paper-based marketing applications in Europe, Japan, Canada, and other regions, and is highly recommended by FDA.
The eCTD format has become mandatory in key regions for electronic submissions. Since January 2010, the European Medicines Agency has required all applications in the centralized procedure use the eCTD format. Since January 2008 FDA CDER has required all electronic submissions be in the eCTD format. FDA CBER requires the eCTD format for priority review and rolling submissions. This course will not only address the content and format of each module and sub-sections of the CTD, but will also demonstrate how the CTD/eCTD can be built throughout development starting with the IND.
This course is designed to identify and review applicable regulatory guidelines (U.S., EU, ICH, and other regional guidances), providing information on the content and preparation of the CTD, and will address specifications and granularity for electronic submissions (eCTD). The course discusses tips for efficient preparation of the CTD with submission-ready reports that can be written early in development and inserted or expanded for marketing applications. The use of CTD mapping and templates to facilitate gap analysis, project management, CMC strategy, and life cycle management will also be discussed in interactive sessions. Case studies will be presented throughout the course to encourage discussions. |
http://www.cfpie.com/showitem.aspx?productid=078&source=labmate |
| Dec 08 2010 - Dec 09 2010 |
Software Development for Medical Device Professionals |
King of Prussia, PA |
Upon completion of this course, you will have gained an understanding of how to effectively meet the requirements of software development design control for medical devices. Particular emphasis will be placed on effective design strategy, as all too often unnecessary time and money is spent on ineffective software design control processes.
The first day will cover topics including regulations and standards, software development, software development procedures and will include software development models and design controls. The second day will discuss software validation of development tools and software used in Manufacturing and throughout the Quality System as well as risk management for software-based medical devices.
Several interactive exercises are used to reinforce principles and concepts. |
http://www.cfpie.com/showitem.aspx?productid=071&source=labmate |
| Dec 13 2010 - Dec 14 2010 |
Good Clinical Practice for Medical Device Investigations |
King of Prussia, PA |
GCP regulations and standards apply to medical device clinical investigations. Failure to conform to these requirements may result in inadequate human subject protection and doubts about data quality and integrity. This course provides a comprehensive overview of the Food and Drug Administration?s (FDA) GCP regulatory requirements and expectations. Course content will prepare attendees for carrying out or reviewing compliance with those regulations and expectations. The course addresses GCP for clinical investigations of all medical device types, including significant risk, non-significant risk and in vitro diagnostic devices. |
http://www.cfpie.com/showitem.aspx?productid=122&source=labmate |
| Dec 13 2010 - Dec 14 2010 |
Overview of FDA Regulatory Compliance for Medical Devices |
King of Prussia, PA |
This course discusses the Agency?s regulatory authority for approving medical devices prior to marketing and the compliance programs used in enforcing its authorities. It also provides FDA strategies towards inspections of manufacturing sites and compliance actions that may result from these. The various regulatory processes are presented including the major enforcement tools such as warning letter, injunctions and civil money penalties. The course provides the attendees with the most important regulatory resource materials needed to understand agency behavior. |
http://www.cfpie.com/showitem.aspx?productid=020&source=labmate |
| Dec 15 2010 - Dec 16 2010 |
Good Clinical Practice Auditing |
King of Prussia, PA |
GCP regulations and standards apply to clinical trials of investigational pharmaceuticals, biologics and medical devices. Failure to conform to these requirements may result in inadequate human subject protection and doubts about data quality and integrity. This course provides a comprehensive overview of how to carry out GCP audits. Course content will prepare attendees for carrying out and following through on internal and external GCP audits. |
http://www.cfpie.com/showitem.aspx?productid=121&source=labmate |