QA Best Practices In A GLP Environment
Wed, June 11 9:00 am – 11:00 am
TO REGISTER
Email your name, title and company to register@massbio.org. Please include "6/11 QR" in the subject line.
This event is free of charge and open to MBC Member companies and their employees only.
For more information on Membership, contact Lori Gold at lori.gold@massbio.org or 617-674-5149
Registration closes at approximately 3pm one day prior to a scheduled meeting. Unless a meeting is closed due to capacity you may attend as a walk-in registrant.
This meeting will be held at the MBC Offices, located on the ninth floor of One Cambridge Center, Cambridge, MA 02142.
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
Andrée Lefebvre, B.Sc., R.A.C., Director, Regulatory Affairs and Assistant Managing Director, Cato Research Canada
PHONE: 617.674.5100
EMAIL: