GMP for Phase 1 Products - Webinar by GlobalCompliancePanel

Website http://bit.ly/1ca7yc9 | Edit Freely

Category Webinar, Health, Medical, Pharma, Clinical

Deadline: September 26, 2013 | Date: September 26, 2013

Venue/Country: USA, U.S.A

Updated: 2013-08-12 16:06:50 (GMT+9)

Call For Papers - CFP

FDA has issued as rule that relieves Phase 1 products from complying with the GMP given in 21 CFR 211. At the same time, they ruled that the products must continue to comply with the GMP as given in the Food, Drug, and Cosmetic Act. Guidance was then given to describe these GMP.

Areas Covered in the Session:

What types of phase 1 products are covered by the rule, and which ones are not.

What is the regulatory basis for the rule.

A description of what is considered to be the GMP under the Food, Drug, and Cosmetic Act, and how it compares to the GMP given in 21 CFR 211.

Who Will Benefit:

Quality control and quality assurance workers.

Regulatory Affairs personnel

Product development workers

Personnel planning clinical studies.

Manufacturing supervisors

Steven S. Kuwahara, Ph.D. is the founder and Principal of GXP BioTechnology LLC, a consulting firm that works in the areas covered by the GLP and GMP of drugs, biologics, and nutraceuticals. Steve has over 30 years of experience in supervising quality control laboratories, including an animal testing facility, and in performing GLP and GMP audits of internal and external testing laboratories .

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Event Link - http://bit.ly/1ca7yc9