Change Control: How to Manage Change Within a GMP Environment

  • March 28, 2019
    9:00 am - 4:30 pm


15 Allstate Parkway, Suite 600, Markham, Ontario, Canada, L3R 5B4

Certification Areas

The course will provide guidance in handling changes that can occur in the pharmaceutical industry. It will help the attendee navigate through the changes from inception to completion while maintaining compliance with Good Manufacturing Practices.

The course will cover steps of a change control and how to determine the actions needed. Topics will include:

• Identification of change
• Writing and implementation of a Change Control Standard Operating Procedure
• Starting the change process
• Proper GMP documentation
• Identifying implementation tasks
• Assigning time lines
• What to do to make change happen
• Evaluation of the effects of the change
• Finalizing the change


SPEAKER: 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.

Student Ticket: $250.00 Sold Out
Basic Member: $650.00 Sold Out
Group 5+ Tickets: $555.00 Sold Out
Pro Ticket: $575.00 Sold Out