Netzealous LLC DBA - Compliance4All, Online
2018-03-22
Overview: 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 Personnel requirements QC Functions 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 Compliance Professionals
Event Fee: One Dial-in One Attendee Price: US$150.00
Contact Detail: Compliance4All DBA NetZealous, Phone: +1-800-447-9407 Email: support@compliance4All.com
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