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
March 28-29, 2012
9:00 a.m. – 5:00 p.m.
CAD $885.00 + HST
AAPS Training Center
200 Consumers Road, Suite 200, Toronto, Ontario, M2J 4R4
Tel: 416-502-2277
A compliant documentation system is of vital importance to a pharmaceutical company because it supports various important functions. It provides the legal proof that work was adequately planned and performed, it helps in the trouble-shooting of technical and managerial problems, it facilitates company growth and technology transfer, it provides a written history of company and products, and it proves to regulators that the company follows its commitments.
This training course provides participants the tools needed to perform in-depth audits of GMP documentation in the pharmaceutical, biopharmaceutical and medical devices including insight on new regulations and methodologies, case studies to help benchmark current practices, and guidelines for following up with corrective actions.
8:30 am - 9:00 am
Registration and Continental Breakfast
9:00am – 9:05am
Opening Remarks
9:05am -10:45am
Conducting Effective Auditing of GMP Documentation
10:45am -11:00am
Mid-Morning Break
11:00am – 12:45pm
Conducting Effective Auditing of GMP Documentation Cont'd
12:45pm -1:45pm
Luncheon
1:45pm – 3:30pm
Conducting Effective Auditing of GMP Documentation Cont'd
3:30pm – 3:45pm
Afternoon Break
3:45pm – 5:00pm
Conducting Effective Auditing of GMP Documentation
8:30 am - 9:00 am
Continental Breakfast
9:00am -10:45am
Conducting Effective Auditing of GMP Documentation Begins
10:45am -11:00am
Mid-Morning Break
11:00am – 12:45pm
Conducting Effective Auditing of GMP Documentation Cont'd
12:45pm -1:45pm
Luncheon
1:45pm – 3:30pm
Conducting Effective Auditing of GMP Documentation Cont'd
3:30pm – 3:45pm
Afternoon Break
3:45pm – 5:00pm
Conducting Effective Auditing of GMP Documentation
This two-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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