Change Control: How to Manage Change Within a GMP Environment

  • February 12, 2019
    9:00 am - 4:00 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 both at the government and private level since graduation. She was involved in performing GMP inspections with Health Products Food Branch Inspectorate. She has also performed chemical analyses both with Health Canada and Industry.

She presently heads up the Eurofins Experchem Laboratories Inc. Regulatory Affairs Department. She also serves as a Regulatory/Quality Control consultant and auditor to clients who are involved in the fabrication, packaging, testing, importation, distribution and wholesaling of Drug Products, Natural Heath Products, Medical Devices, and Medical Marihuana.

Student Ticket: $250.00 On Sale
Basic Member: $650.00 On Sale
Group 5+ Tickets: $555.00 On Sale
Pro Ticket: $575.00 On Sale