Calendar

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.

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).

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.

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.

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

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

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.

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.

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.

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.

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.

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.

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

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.

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.

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.

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.

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

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

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.

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.

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

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

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.

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.

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.

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

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.

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

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.

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.

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.

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.

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.

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.

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

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.

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.

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.

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).

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.