Training & Events

Day 1 (May 13, 2024) - Corrective Actions & Preventive Actions (CAPA) Workshop

The investigations of anomalies and deviations are a requirement under the Canadian Food and Drug Regulations, Division 2, namely the Good Manufacturing Practices. This investigation involves the identification of Corrective Actions and Preventive Actions, which are commonly referred to as CAPA. 

If you're interested in learning how to conduct a proper CAPA investigation and create a comprehensive CAPA Report, this course is for you. The course will guide you through the process of identifying the flow of the investigation and collecting necessary information or data that can be used to create a GMP Compliant CAPA report. 

By enrolling in this course, you will gain the knowledge and skills required to conduct a thorough and fully compliant investigation. You will also learn how to define the criteria for a successful investigation, ensuring that your efforts are always effective and impactful.

Course Outline:

Writing and implementation of a CAPA Standard Operating Procedure
Starting the process
Assigning timelines
Identifying areas that are to be investigated and the process for such investigation
Gathering the information/data
Evaluation of the information/data
Writing the report
Finalizing the report
Follow up on the Preventative Actions

Day 2 (May 14, 2024) - Change Control Workshop

In today's rapidly evolving pharmaceutical industry, it's crucial to stay updated on the latest changes to maintain compliance with Good Manufacturing Practices. This course is designed to guide attendees through the entire process of navigating these changes, from start to finish. By participating, you'll gain valuable insights and practical strategies for effectively managing shifts in the industry - all while ensuring that your company stays fully compliant. Don't miss out on this opportunity to stay ahead of the curve and enhance your skills!

Course Outline:

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

Time:  9:00 AM - 4:30 PM CST

Location:  MPR 2 - 100 Innovation Drive, UM Smart Park, Winnipeg, MB

PRICING:

May 13 - Corrective Actions & Preventative Actions (CAPA) Workshop only

Members:  $440 + GST |  Non-Members:  $615 + GST

May 14 - Change Control Workshop only

Members:  $440 + GST |   Non-Members:  $615 + GST

May 13 & 14 - both workshops (BEST VALUE)

Members:  $815 + GST  |   Non-Members:  $1150 + GST

Pricing includes:  all training material, Certificate of Completion, Lunch and refreshments.

Instructor Information:

Ms. Terry Pilkey has been involved in the pharmaceutical industry at both the government and private level for 44 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 for both Health Canada and the industry. She has recently retired from her position as the Regulatory Affairs Director at Eurofins Biopharma Product Testing Toronto, Inc., where she served as the 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 Medical Cannabis.