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

Event Information
2 Days
Left To Register
Product Format
Live Webinar
Peggy J. Berry, MBA, RAC
Conference Date
Add to my calendar   Tue, Oct 24, 2017
Aired Time
1 pm ET | 12 pm CT | 11 am MT | 10 am PT
90 minutes
Product Description

Explore FDA Guidance for Phase 1 Investigational Drugs

Current good manufacturing practices (CGMPs) for FDA Phase 1 clinical trials are a common source of questions for drug manufacturers. In Phase 1, drugs are given to humans, and there are a seemingly countless array of safeguards that the FDA requires in the process. Documenting CGMPs is an essential part of those safeguards.

This session by expert speaker Peggy Berry will overview the FDA’s current regulations and guidance documents for CGMP documentation in detail. She will discuss regulatory strategies and logistical considerations for drugs in their early development stages, and issues including vendor selection and management, stability, labeling and documentation requirements. After this session, you will understand the differences between CGMP requirements for early and later stage clinical development. You will also be able to develop and implement strategies for proper CGMP documentation.

Session Highlights

  • IND and NDA content and format for CMC information
  • Vendor selection and management for outsourcing early manufacturing
  • Raw material selections and considerations
  • Required SOPs and documentation

Who Should Attend

  • Directors
  • Managers
  • Supervisors in Regulatory Affairs
  • Manufacturing Personnel
  • Quality Assurance Professionals
  • Clinical Operations Personnel

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

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About Our Speaker

Peggy J. Berry

Peggy J. Berry, MBA, RAC, is the president and 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, Peggy was Vice President of Regulatory Affairs at Insmed where she was responsible for the development and implementation of...   More Info
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