FDA's Current Thinking for Industry cGMPs for Phase 1 INDs

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.

Who Will Benefit:

This webinar will provide valuable assistance to those persons producing drugs and biological products (investigational drugs) for use during phase 1 development in complying with US CGMP requirements. The employees who will benefit include:

• Management
• Production employees
• Quality Control managers and Personnel
• Process Chemists and personnel
• Laboratory personnel

Instructor Profile:

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.