Understand FDA’s Latest Thinking on Industry cGMPs for Phase 1 INDs| Oct. 25, 2013, 2 PM EDT | Whestone
August 22nd, 2013 // 7:19 pm @ jmpickett
This new Webinar, presented by a former FDA investigator, will give you a unique, insider view on the new FDA cGMP guidance and regulations for Phase 1 INDs.
Background
FDA has issued a draft guidance document outlining a suggested approach to complying with current GMPÂ requirements for drugs intended solely in Phase 1 studies.With this guidance and an accompanying regulation, 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.
What You Will Learn
- 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
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 cGMP requirements. The employees who will benefit include:
- Management
- Production employees
- Quality Control managers and Personnel
- Process Chemists and personnel
- Laboratory personnel
What You Receive
With your order, we would like to offer you these six items at no added cost:
- Powerpoint slides to share
- Downloadable recording or CD
- Article – 21 CFR Part 11 Enforcement – Where Is FDA Headed? By John Avellanet, Cerulean Associates
- Article – 10 Ways to Control Compliance Costs – By John  Avellanet, Cerulean Associates
- Guide – An Executive Guide to Quality by Design – By John Avellanet, Cerulean Associates
- Newsletter – FDA Digest – By Expertbriefings.com. Latest FDA regulatory news, and recent 483 and warning letter analysis – 12 issues only $399.00
About the Speaker
Sandra 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.
