The investigations of anomalies and deviations are a requirement under the Canadian Food and Drug Regulations, Division 2, namely the Good Manufacturing Practices.
The investigation includes the determination of the Corrective Actions and Preventative Actions. This is referred to as CAPA.
The course will provide guidance in the CAPA investigation and creating the CAPA Report.
It will help the attendee navigate through the process of determining the flow of the investigation and the gathering of the information/ data that is required to be assessed through to the creation of a complete GMP Compliant CAPA report.
The course will cover the steps of the CAPA process and how to determine the criteria for a full compliant investigation to occur.
Topics will include:
- Writing and implementation of a CAPA Standard Operating Procedure
- Starting the process
- Assigning time lines
- 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
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: 26 Oct 2020
|Student Ticket:||$200.00||— Sold Out|
|Basic Member Regular:||$445.00||— Sold Out|
|Pro Ticket Regular:||$395.00||— Sold Out|