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

This US FDA final guidance documentation training program will give an insider’s insight into the final guidance and discuss the rationale for such. The course will also elaborate CGMP statutory and regulatory requirements and recommendations for complying with the statue.

Why Should You Attend:

The US FDA has issued a final guidance document outlining a suggested approach to complying with current good manufacturing practice (CGMP) requirements for drugs intended solely in Phase 1 clinical trials. 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 insider’s insight into the new guidance and regulation and discuss the background and rationale for guidance and regulation.

Areas Covered in the Webinar:

• Background and rationale for guidance and regulation
• Scope
• CGMP statutory and regulatory requirements
• Recommendations for complying with the statue- personnel, quality control function, facility and equipment, control of components and containers and closures, manufacturing and records, laboratory controls, packaging, labeling and distributing and recordkeeping
• Special manufacturing 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