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.

Why Should You Attend:

The US FDA has issued a draft guidance document outlining a suggested approach to complying with current good manufacturing practice (CGMP) requirements for drugs intended soley in Phase 1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.

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