Webinar on The FDA Good Manufacturing Practices (GMP) for Drugs and Biologics

MessageThis Webinar is over
Date Jul 23, 2014
Time 13:00 pm
Cost $249.00
Online
This webinar is a must for those personnel that require an understanding of the regulation governing manufacturing operations. FDA’s regulates the manufacture of Drugs and Biologics under the Good Manufacturing Practices (GMP) regulation 21 CFR Parts 210-211.
FDA regulates the manufacture of Drugs, Biologics and Veterinary products in the USA under a regulation called the Good Manufacturing Practices (GMP) Regulation. This webinar will address the reasoning for and requirements of the GMP. Every section of the GMP (Subparts A – Subpart K) plus the Introduction in 21CFR Part 210 will be reviewed and discussed. FDA’s “umbrella” approach to the GMP will be discussed and FDA interpretations of the GMP reviewed. This webinar will provide an understanding of the intent and expectations of FDA relative to the GMP.

Areas Covered in the Session :
FDA’s GMP regulation
Understanding Parts 210-211
Understanding Subparts A-K
Understanding of the GMP regulation
FDA’s "umbrella" approach
Interatcive Q&A session

Who Will Benefit:
Regulatory Affairs Personnel
Quality Personnel
Clinical Personnel
Research Personnel
Laboratory Personnel
Manufacturing Personnel
Legal Personnel
Auditors
Clinical Research Associates
Personnel who require a general understanding of the FDA’s GMP regulation – 21CFR

 


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