GMP for Phase I Investigational Drug Products 2018

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Category Clinical Trials, Good Manufacturing Practices, compliance procedures, clinical compliance training, usp good documentation practices, Specialists courses

Deadline: March 21, 2018 | Date: March 22, 2018

Venue/Country: Online, U.S.A

Updated: 2018-01-30 16:19:18 (GMT+9)

Call For Papers - CFP

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: supportcompliance4All.com