Regulatory Readiness in 2013 - Comprehensive Compliance Training Package for Pharma Companies (8 Courses)

The FDA’s increasing scrutiny of drug companies, the record fines handed out to firms in 2012 and the strengthening of existing regulations go to show that 2013 will not be any easier for organizations when it comes to compliance. But what are the common regulatory pitfalls that companies need to avoid and how can they ensure their compliance programs are robust enough to keep on the good side of the FDA?

This package of eight webinar recording CDs covers compliance requirements that could be the most scrutinized by regulators in 2013. Topics covered include: FDA’s Current Thinking for Industry cGMPs for Phase 1 INDs; Raw Materials Risk Management in GMP Facilities; An Introduction to FDA’s Regulation of Over-the-Counter (OTC) Drug Products; Drug Master Files; Dietary Supplement Regulatory Compliance; FDA’s Regulation of Veterinary Regenerative Medicine; QbD Approach to Analytical Method Lifecycle Design, Development, Validation, Transfer Goals and Objectives; and Proven Root Cause Investigation Techniques for Pharmaceutical Water Systems.

How It Works:

Each webinar CD has a series of modules. Our speakers have delivered the modules using PowerPoint slides.

This training is convenient to attend individually or in groups. You don’t have to travel from your office. This means you can afford to have your whole team attend. As the webinar recording CDs are licensed to be used multiple times in a location, you can schedule the training as many times for as many groups/batches as you wish. Your team members will learn the material together; everybody will get the same information.

Webinar Topics:

Module 1: FDA’s Current Thinking for Industry cGMPs for Phase 1 INDs
Module 2: Raw Materials Risk Management in GMP Facilities: Avoiding GMP non-Compliance Due to Raw Material Issues
Module 3: An Introduction to FDA’s Regulation of Over-the-Counter (OTC) Drug Products
Module 4: Drug Master Files - Understanding and Meeting your Global Regulatory and Processing Responsibilities
Module 5: Dietary Supplement Regulatory Compliance in the United States: Labeling, Product Claims & Updates from the FDA
Module 6: FDA’s Regulation of Veterinary Regenerative Medicine: What Industry Needs to Know to Market and Sell a Stem Cell Product for Use in Dogs, Cats, Horses and other Animals
Module 7: QbD Approach to Analytical Method Lifecycle Design, Development, Validation, Transfer Goals and Objectives
Module 8: Proven Root Cause Investigation Techniques for Pharmaceutical Water Systems

Who will Benefit?

These webinar recording CDs will be beneficial to all professionals working in the pharmaceutical and dietary supplement industry, but specially:

• Regulatory Affairs Managers
• Management
• Production employees
• Quality Control managers and Personnel
• Process Chemists and personnel
• Laboratory personnel
• Manufacturing
• Validation
• Documentation

Webinars Iincluded in the Package:

Module 1 : FDA’s Current Thinking for Industry cGMPs for Phase 1 INDs (Duration: 60 minutes)
1 CD Price: $499

This webinar, by a former USFDA executive, will provide an insider's insight into the new guidance and regulation for Phase 1 INDs, and discuss the rationale for such.

Areas Covered in the Webinar:

• Background and rationale for guidance and proposed regulation.
• Scope.
• CGMP Statutory and Regulatory Requirements.
• Recommendations for complying with the statue- personnel,Quality Control Function, facility and Equipment, Control of Components, Production and Documentation, Laboratory Controls,Container Closure and Labeling, Distribution and Record keeping.
• Special production situations.
• Biological and Biotechnological Products.
• Sterile products/aseptically processed products.
• Questions.

About the Instructor:

Sandra N. Whetstone is a former (retired) US Food and Drug Administration (FDA) executive. She has more than 35 years of experience as a US Food and Drug official and is a recognized expert in US Food and Drug Law, the Public Health Service Act and related statues. Mrs. Whetstone is a co-founder and Managing Director of Comprehensive Compliance Solutions, LLC, a consulting company specializing in all aspects of FDA regulatory compliance matters relative to human and veterinary drugs, biologics, medical devices and foods. She has developed and presented cGMP training courses for Phase 1 and Phase II pharmaceutical manufacturers.

Module 2 : Raw Materials Risk Management in GMP Facilities: Avoiding GMP non-Compliance Due to Raw Material Issues (60 Minutes)
1 CD Price: $499

This webinar will help you understand the current requirements for raw material management with tips about practical implementation. It covers FDA's expectations from GMP facilities regarding raw material vendor selection, measures for assuring acceptable quality of material supplied, expectations from quality control and documentation processes, and training requirements, with case studies.

Areas Covered in the Webinar:

• FDA requirements for raw material management at GMP facilities.
• Common risk management practices.
• Vendor selection and validation requirements.
• Product specific raw material issues: chemical, biologic and botanical raw materials.
• Suggested quality control measures.
• FDA's common findings and possible resolutions.
• Trends in FDA inspection of raw material processes.
• Regional and multinational raw material providers.
• Raw material risk management in the global setting.

About the Instructor:

Dr. Mukesh Kumar leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD. His key expertise is in regulatory affairs, clinical trials and multi-national project management for medicinal and diagnostic products. He has been involved in about 100 clinical trials in more than 40 countries, has made several hundred US FDA submissions, and arranged a number of meetings with the US FDA.

Module 3 : An Introduction to FDA’s Regulation of Over-the-Counter (OTC) Drug Products (60 minutes)
1 CD Price: $449

This webinar will provide an introduction to the FDA's regulation of Over-the-Counter (OTC) drug products and the various methods for bringing such a product to market. You will learn the various options for marketing an OTC drug, gain an understanding of FDA's relevant labeling and promotional rules, and learn strategies for mitigating the potential risk for FDA regulatory enforcement.

Areas Covered in the Webinar:

• FDA's regulation of over-the-counter drug products or OTC drugs.
• Bringing an OTC drug to market under an OTC monograph.
• Where to find FDA's list of existing monographs and identification of the various product categories covered by monographs.
• An introduction to FDA's Rx-to-OTC Switch procedures and the benefits / challenges of pursuing such an option.
• Labeling an OTC drug product.
• Potential FDA enforcement risks.

About the Instructor:

Karl Nobert, is a food and drug regulatory attorney with the law firm of Squire Sanders in Washington, DC. He provides regulatory advice and counseling to domestic and international pharmaceutical, OTC and consumer product companies on issues related to the U.S. Food and Drug Administration's regulation of the manufacture, labeling, distribution, marketing and sale of drugs, dietary supplements, devices and food.

Module 4 : Drug Master Files - Understanding and Meeting your Global Regulatory and Processing Responsibilities (6 Hours)
1 CD Price: $1,099

This DMFs (Drug Master Files) training will discuss the current review and enforcement climate within FDA and the manner in which drug master files (DMFs) are reviewed by FDA personnel. Besides the US, the use of DMFs in the EU, Japan, Canada and Australia will also be discussed. Similarities and differences to the U.S. system will be highlighted.

Areas Covered in the Webinar:

• What are DMFs?
• The rationale and preparation process for DMFs.
• DMF Preparation: What you need and why you need it.
• FDA Review: How FDA reviews DMFs and why.
• Components Associated with a DMF:
• Japan DMFs.
• European DMFs.
• Canadian DMFs.
• Change control and maintenance: Why accurately maintaining your DMFs is important.

About the Instructor:

Robert J. Russell, is President and CEO of RJR Consulting, Inc, a leading Global Regulatory Consulting firm focusing on assisting the Life Science Industry. Prior to founding the firm in 2000, Mr. Russell had over 27 years of experience in CMC, Global Business Development and Regulatory Compliance for pharmaceuticals, biologics, medical devices and combination products.

Module 5 : Dietary Supplement Regulatory Compliance in the United States: Labeling, Product Claims & Updates from the FDA (90 minutes)
1 CD Price: $599

This 90 minute interactive webinar will review the dietary supplement regulations and discuss how to verify that your products are compliant, while citing differences with food and drug regulations.

Areas Covered in the Webinar:

• Dietary Supplement Overview.
• Regulatory Structure.
• History of Dietary Supplement Regulation.
• Manufacturing Considerations.
• Dietary Ingredients.
• Labeling Considerations.
• Advertising Considerations.
• Questions & Answers.

About the Instructor:

James Russell, is the Director of Regulatory Affairs and Business Development for RJR Consulting Inc, a leading global regulatory consulting firm servicing the Life Science and Consumer Products industries. Mr. Russell has 13 years of experience in the Life Science field, encompassing foods, dietary supplements, medical devices and pharmaceuticals.

Module 6 : FDA’s Regulation of Veterinary Regenerative Medicine: What Industry Needs to Know to Market and Sell a Stem Cell Product for Use in Dogs, Cats, Horses and other Animals (60 minutes)
1 CD Price: $549

This webinar will provide an introduction to FDA's regulation of veterinary regenerative medicine and highlight the regulatory requirements that a biotech company needs to satisfy to commercialize a stem cell or other complex biotech product for animal use in the U.S.

Areas Covered in the Webinar:

• Who regulates veterinary cellular and tissue products; and biotherapeutic products intended for commercialization.
• FDA's regulation of veterinary regenerative medicine including stem cells and other biotherapeutics.
• FDA's currently regulation of human cellular and tissue products; and how those same regulatory policies may be applied to veterinary products.
• Discussion of the new animal drug approval process.
• The potential for a drug / non-drug distinction to be made between products based on the amount of processing applied to the product.
• What are the requirements for labeling, marketing and advertising such a product.
• Strategies for mitigating FDA enforcement risks.

About the Instructor:

Karl Nobert, is a food and drug regulatory attorney with the law firm of Squire Sanders in Washington, DC. He provides regulatory advice and counseling to domestic and international pharmaceutical, OTC and consumer product companies on issues related to the U.S. Food and Drug Administration's regulation of the manufacture, labeling, distribution, marketing and sale of drugs, dietary supplements, devices and food.

Module 7 : QbD Approach to Analytical Method Lifecycle Design, Development, Validation, Transfer Goals and Objectives (120 minutes)
1 CD Price: $599

This webinar will provide you a comprehensive understanding of the requirements for validation, verification and transfer of pharmaceutical analytical methods. A lifecycle approach will be presented to establish the expectations for the method, after which key guidance documents will be reviewed.

Areas Covered in the Webinar:

• Assessment of Participants Needs.
• Validation, following ICH Q2 and USP <1225>.
• Verification of Compendial Methods.
• Transfer of Analytical Methods Between Laboratories.
• When to do validation, verification and transfer apply?
• Designing Validation Experiments to minimize time and resources.
• Sensible pre-validation experiments.
• Writing validation protocols and establishing practical acceptance criteria.
• Writing validation reports.
• Troubleshooting unexpected results.

About the Instructor:

Greg Martin, is President of Complectors Consulting which provides consulting and training in the area of Pharmaceutical Analytical Chemistry. He has particular interest in QbD/Lean approaches to dissolution testing, impurity methods, method lifecycle (development/validation/transfer) and instrument qualification, and is passionate about using good science and sound logic to achieve high quality results, consistent with cGMPs, while minimizing resources.

Module 8 : Proven Root Cause Investigation Techniques for Pharmaceutical Water Systems (90 minutes)
1 CD Price: $500

In this Water System Webinar the author will explain the process he uses as a consultant for investigating and solving water system or product contamination problems with water organisms. Case studies of real life problems he has resolved will be presented to illustrate the process. Though there is no rule book or SOP for such contamination problem solving, learn the best practices of solving these problems from an expert.

Areas Covered in the Webinar:

• Early information; gathering and assessing user opinions.
• Investigation approach elements-- the various rocks to be turned over.
• Five water system/product contamination case studies.
• Seven kernels of water system investigation wisdom.

About the Instructor:

T.C. Soli, Ph.D , is President of Soli Pharma Solutions, Inc, with lecturing, auditing, and troubleshooting expertise covering water systems, sterilization, aseptic processing, contamination control, and microbiological laboratories. He has over 31 years of pharmaceutical experience as a consultant and with DSM Pharmaceuticals, Glaxo Wellcome, Burroughs Wellcome, and Pfizer. Dr. Soli's career-long water systems and contamination troubleshooting, coupled with water-related USP, ISPE, PhRMA, and PDA committee involvements, afford him practical knowledge about process and contamination control; cleaning, sterilization and process validation; and all aspects of high purity water systems.

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