Working in a GMP Environment
*January 2021*
Course Description
This is our regular 2-day GMP course adapted for online presentation. This interactive course provides a fresh dynamic every time you take it and offers alternative approaches to problem-solving. Hands-on exercises enable participants to map their individual GMP responsibilities and gain the skills and knowledge necessary to understand and work in a GMP compliant environment and contribute to the ongoing quality of their company. Group exercises and ample opportunity to share real-life experiences provide the participants with the added benefit of learning from their peers as well as the instructor.
Note: Health Canada released revised guidelines to the GMP Regulations GUI-0001 which became effective on July 1st, 2020. This course will include and cover these updates.
Course Objective
This 4-x half-day workshop (12:30 pm – 4:30 pm each day) will cover the following topics:
Session 1
–Introduction and overview of GMP
–Summary of Updates to GUI-0001 (July 1st, 2020)
–Introducing the Quality Management System (QMS)
–Regulations
*Premises, sanitation, and equipment
*Personnel, training, qualifications, and responsibilities
Session 2
–Regulations
–Laboratory controls, Test Procedures and Specifications
–Raw Material Testing
–Manufacturing Controls, Packaging, and Labeling Controls
–Quality Control Department
–Packaging Material Testing
–Retain Samples
Session 3
–Regulations
*Finished Product Testing
*Stability
*Record Keeping
–Data Integrity
Session 4
–Summary of good documentation practices
–Supporting Quality Systems/Functions for GMP Compliance
*Outsourced activities
*Standard Operating Procedures (SOPs)
*Validation
*Change control
*Deviations/Non-Conformance
*Product Complaints and Recall
*Self-Inspection
*Annual product Review
–Overview/Summary
Who Should Attend
Personnel in the pharmaceutical and related industries with at least 1-year experience of working in a GMP environment or has experience with an equivalent quality system (e.g. medical devices).
Personnel from quality assurance, manufacturers, packagers, labelers, laboratories, regulatory affairs, importers, distributors, wholesalers, and auditors.
This course would be particularly suitable for those
–requiring a refresher course to “get back to basics”
–interested in GMP updates and their implications
–wishing confirmation of their day to day GMP compliance activities.
–who participates/are responsible for training their own company employees in GMP related activities
–are part of a smaller company that requires annual GMP training.
–who are involved in internal or external auditing
Based on current versions of:
–Health Canada GUI-0001 Good Manufacturing Practices for Drug Products
–FDA part 211 Current Good Manufacturing Practice for Finished Products
Course Leader
Dr. Pauline McGregor, Ph.D. Chem, MRSC
Pauline McGregor, Ph.D. CChem MRSC has over 30 years of experience in the pharmaceutical industry. She is an expert in quality systems and procedures, GMP regulations, and analytical chemistry. She has utilized her skill set globally in the UK, Canada, US, Jordan, Brazil, and China and has helped companies prepare for a GMP inspection to gain their European/Health Canada/FDA GMP licenses. She is often asked to perform self-inspections for companies as an extension of their quality group.
Throughout her career, she has identified a lack of shared knowledge between Manufacturing, Quality Control, R & D, and Quality Assurance sectors in the Healthcare Industries. She believes there is a need for cross-education and training to allow the different disciplines to communicate with each other so that realistic objectives can be met by all in a timely manner with a harmonized understanding.
As a USP volunteer, Pauline was a proud member of the initial USP expert panel for Validation, Verification, and Transfer of Analytical Procedures and a member of a USP Chemical Medicines Monograph expert review committee. She continues to be a USP expert volunteer. Pauline is also a member of The Royal Society of Chemistry, UK, and is listed on their current directory for consultants.
Registration Deadline: 7 Jan 2021
Basic Member Ticket: $725.00 — On Sale Until: 06/01/21 4:15 PM
Student Member Ticket: $625.00 — On Sale Until: 06/01/21 4:15 PM
Pro Member Ticket: $625.00 — On Sale Until: 06/01/21 4:15 PM
Pro Plus Ticket: $625.00 — On Sale Until: 06/01/21 4:15 PM
