FDA's GMP Expectations for Phase I and First-in-Man Clinical Trials


Early clinical trials are conducted to establish initial safety of a drug. The studies are generally in small number of healthy subjects and use lower doses of the drug product. Therefore, only small amounts of investigational material are required. In order to not undertake substantial costs and to reduce regulatory burden during these early stages, the FDA has established guidelines to allow early stage investigational products to be manufactured under less stringent GMPs.

Course Objective:

To gain an understanding of the requirements for advancing drugs from research into early clinical development and the minimum FDA requirements for phase I GMPs. To learn practical applications for implementing phase I manufacturing strategies to meet FDA requirements. This webinar will provide the foundation and basis for advancing drugs into clinical development from research and providing required information to the FDA regarding these products. It will provide valuable guidance to provide the requirements for early stage products of different types and for vendor selection and management.

Course Outline:

• Moving a Product out of R&D
• CMC Requirements for an IND Study
• Good Manufacturing Practices: Basics for Beginners
• Raw Material Management
• GMPs for Phase 1 IND products
• GMPs for Combination Products and 505(b)(2) Products
• Process Validation for Early Stage GMP
• Outsourcing Early Stage Manufacturing

What You Get:

•  Training Materials
•  Live Q&A Session with our Expert
•  Participation Certificate
•  Access to Signup Community (Optional)
•  Reward Points

Who Will Benefit:

• Directors
• Manager
• Supervisors
• Lead workers in Regulatory Affairs Quality Assurance and Quality Control
• Workers who will prepare GMP documents for early phase products
• Workers who will review GMP documents for early phase products
• Regulatory affairs workers who will need to deal with submissions covering early phase products

Peggy J Berry,

Peggy J. Berry, MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics. Prior to founding Synergy Consulting in 2015, she was Vice President of Regulatory Affairs at Insmed (2/2015-5/2015) where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs department. Prior to Insmed, she was Vice President of Regulatory Affairs and Quality at Amarin (3/2009-2/2014). She has also held a variety of senior level positions at Dyax (5/2006-3/2009), MGI Pharma (now Eisai; 7/2005-5/2006), AstraZeneca (10/2001-7/2005), and Dey Pharma (now Mylan; 12/1997-10/2001). She has also held Regulatory Affairs roles within two clinical contract research organizations (ILEX Oncology and Cato Research Ltd; 1992-1997) and has worked in review divisions at the FDA (1985-1992). In addition, Ms. Berry consults for a number of companies in the regulatory and quality area, conducts a number of training courses, and is active in the Regulatory Affairs Professionals Society. She is the editor of the 2010 book “Choosing the Right Regulatory Career” (RAPS, MD) and author of the 2011 book “Communication & Negotiation” (RAPS, MD).

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register

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