This web seminar presents an overview of FDA’s GLP regulation – 21 CFR Part 58. The FDA GLP regulation complies with all GLP requirements globally. This web seminar covers every section of the FDA GLP regulation, offers FDA interpretation and provides an understanding of nonclinical safety research on a global basis. The web attendee with obtain a foundation of knowledge about FDA, the GLP regulation and nonclinical studies.
This webinar is a must for those personnel that require an understanding of the regulations governing laboratory activities relative to nonclinical testing that support or are intended to support applications for products regulated by FDA.
Areas to be Covered:
FDA’s GLP regulations: 21 CFR Part 58
Objectives and concepts of GLP
Required GLP Studies
Responsibilities of different personnel
Data generation and evaluation
How to implement GLP’s
FDA interpretation of 21CFR Part 58
Who will Benefit:
Regulatory Affairs Personnel
GLP study directors
Clinical Research Associates
Personnel who require a general understanding of the FDA’s GLP regulation – 21 CFR Pa