The Annual Product Quality Review is a requirement under the Canadian Food and Drug Regulations, Division 2, namely the Good Manufacturing Practices.
This particular course will provide guidance in creating the Annual Product Quality Review Report. It will help the attendee navigate through the process of determining the information/data that is required to be assessed through to the creation of a complete Annual Product Quality Review report. In addition, the course will cover the steps of the Annual Product Quality Review process and how to determine the criteria for inclusion in the report through to creating a GMP Compliant Report.
Topics will include:
- – Writing and implementation of an Annual Product Quality Review Standard Operating Procedure
- – Starting the process
- – Assigning timelines
- – Identifying areas that are to be assessed
- – Gathering the information/data
- – Evaluation of the information/data
- – Writing the report
- – Finalizing the report
- – Creating subsequent Annual Product Quality Review Reports.
The course materials and access link will be sent to all registrants closer to the course date.
SPEAKER: Ms. Terry Pilkey
Ms. Pilkey has been involved in the pharmaceutical industry at both the government and private level for 39 years. She was involved in performing GMP and Medical Device inspections with the Health Products Food Branch Inspectorate of Health Canada. She has also performed chemical analyses both with Health Canada and Industry.
She presently heads up the Eurofins Biopharma Product Testing Toronto, Inc. Regulatory Affairs Department. She also serves as a Regulatory/Quality Control consultant and auditor to clients who are involved in fabrication, packaging, testing, importation, distribution, and wholesaling Drug Products, Natural Health Products, Medical Devices, and Medicinal Cannabis.
Registration Deadline: 12 Feb 2021
|Student Ticket:||$200.00||— On Sale||Until: 12/02/21 4:35 PM|
|Basic Member Regular:||$445.00||— On Sale||Until: 12/02/21 4:35 PM|
|Pro Ticket Regular:||$395.00||— On Sale||Until: 12/02/21 4:35 PM|