QA Best Practices In A GLP Environment
from Massachusetts Biotechnology Council
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Wednesday, June 11, 2008, 9:00am - 11:00am
This presentation will detail how companies can establish systems and procedures to assure GLP compliance in nonclinical laboratory studies to support drug development.
Specifically addressed will be the requirements for a quality assurance unit as indicated in Section 58.35 of 21 Code of Federal Regulations Part 58, Good Laboratory Practices for Nonclinical Laboratories Studies that states:
"A testing facility shall have a quality assurance unit which shall be responsible for monitoring each study to assure management that the facilities, equipment, personnel, methods, practices, records, and controls are in conformance with the regulations in this part."
Speaker
Andree Lefebvre, B.Sc., R.A.C., Director, Regulatory Affairs and Assistant Managing Director, Cato Research Canada
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