Phase I clinical trials are the first time that investigational new drugs are introduced into human subjects and, although it is very, very important for all drugs to be manufactured using GMPs, it is probably more important than at any other time during the lifecycle of the product, that a product be safe whenever humans are being exposed to it for the first time.
Why should you Attend:
FDAs guidance document "Good Manufacturing Practice for Phase I Investigational Drug Products" applies to correct GMP requirements to drug products made for the purpose of using an investigational drug product on human subjects for the first time, during conduct of Phase I clinical trials, which can begin if your IND is not put on clinical hold in 30 days after receipt by the FDA.
Areas Covered in the Session:
Statutory and Regulatory Requirements
Facility and Equipment Requirements
Control of Components and Containers and Closures
Manufacturing and Records
Who Will Benefit:
Senior Quality Managers, Quality VPs
Quality Associates or Specialists
Regulatory Management or Regulatory Specialists
Stephanie Cooke is the President/CEO of Cooke Consulting, Inc. Stephanie uses her roughly 20 years of experience to provide global consulting services in various areas of Regulatory Affairs, Quality Assurance and validation for pharmaceutical, biological/biotech products, medical device, combination drug/device and nutraceutical firms.
Event Fee: One Dial-in One Attendee Price: US$150.00