Compliance Trainings, Canada
2014-07-24
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 Parts 210-211 Price Tags: Live Single Live : For One Participant $ 249 Corporate Live : For Max. 10 Participants $ 899 Recording Single REC : For One Participant - Unlimited Access for 6 Months $ 299
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