Dr. Mary Mazur-Melnyk was educated in Toronto and holds a M.Sc. in Medical Sciences and a Ph.D. in Molecular Biology. She brings to the table over 20 years of experience in Biologics, Medical Devices and Biopharmaceutical industries. She has held senior level position in the areas of Regulatory Affairs and Quality Assurance at Aventis Pasteur, GSK, Novartis and most recently for Biovail Corporation as their Corporate Vice President of Quality. Currently, she is a Senior Partner with Innovalinks Quality Consultants (IQC), which specializes in the areas of Regulatory and Quality systems. She has extensive experience in the areas of technology transfer, R and D streamlining, and global regulatory approvals of NCEs.
Presentation Materials, Luncheon, Refreshment and Free Parking
Note: Please indicate any special Dietary requirements when registering for the course
February 15, 2012
9:00 a.m. – 5:00 p.m.
CAD $675.00 + HST
AAPS Training Center
200 Consumers Road, Suite 200, Toronto, Ontario, M2J 4R4
Tel: 416-502-2277
I. Regulatory Requirements for GMP Documents
II. Basic Requirements and Techniques for Batch Record Review
III. Techniques for Performing a Technical Review and Conducting Follow-Up Investigations
IV. Workshop - Review of a Mock Batch Production Record
V. Documentation GMP and Regulatory Trends
This one day course is valuable for Directors, Managers, Supervisors, Associates in the Pharmaceutical, Biopharmaceutical, Vitamins, Herbals, Medical Devices and allied industries with daily responsibilities in the following areas:
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