GMP for Phase I Investigational Drug Products 2018

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

Speaker Profile:
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

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]

Others Details

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