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

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

Instructor Profile:

Sandra N. Whetstone is a former US Food and Drug Administration (FDA) executive with 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. Her primary area of expertise is in the practical application of the US Food, Drug and Cosmetic Act, promulgating regulations under the acts, developing and implementing compliance programs for the FDA regulated industries, and developing enforcement strategies for effective compliance and consumer protection covering the full range of products under FDA’s jurisdiction.

In her most recent position as Director of the Division of Compliance Management and Operations, Office of Enforcement, Office of Regulatory Affairs, U.S. Food and Drug Administration, she provided strategic and policy leadership to a division staff with oversight over all of the Agency’s regulatory and administrative actions involving: pharmaceuticals (humans and veterinary), biologics, medical devices, food, including dietary supplements, and cosmetics. Ms. Whetstone was in the approval chain for all of the Agency’s compliance programs and policy documents. She directed the Agency’s recall operations and led a major reengineering of the Agency’s recall procedures. She has conducted numerous seminars for the industry as well as the states and other governments. She developed and conducted internal professional training for agency personnel to ensure consistent application of the laws and relevant scientific and technical standards.

Mrs. Whetstone spent the first part of her FDA career in the FDA’s Bureau of Foods (predecessor to the Center for Food safety and Applied Nutrition) where she served as an analytical chemist prior to moving into the area of regulatory affairs as a compliance officer. Her food experience includes serving as Director of the Program and Enforcement Branch in the Office of Seafood in FDAs Center for Food safety and Applied Nutrition, where she had oversight of the Agency’s seafood program including the Cooperative Shellfish Program. Ms. Whetstone's international experience regarding food import issues is extensive. She has conducted numerous visits to major food producing nations and trained commercial producers and government agencies on U.S. market requirements and regulatory standards. She directed and coordinated the development of numerous compliance programs for all segments of the food industry. She also represented the agency in many national and international forums.

Follow us :