This US FDA draft guidance documentation webinar/ training will give an insider’s insight into the new guidance and regulation and discuss the rationale for such.
The US FDA has issued a draft guidance document outlining a suggested approach to complying with current good manufacturing practice (CGMP) requirements for drugs intended soley in Phase 1 studies.With this guidance and an accompanying regulation, US FDA formally recognizes specific standards for the manufacture of small amounts of drug products for phase 1 studies and formulating an approach to cGMP compliance that is appropriate for the particular stage of drug development. This presentation will give an insiders insight into the the new guidance and regulation and discuss the rationale for such.
Areas Covered in the seminar:
- 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
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.
