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.
This 4-x half-day workshop (12:30 pm – 4:30 pm each day) will cover the following topics:
Jan 12th – Session 1
• Introduction and overview of GMP
• Summary of Updates to GUI-0001 (July 1st, 2020)
• Exercise – Mapping personal GMP responsibilities
• Introducing the Quality Management System (QMS)
o Premises, sanitation, and equipment
o Personnel, training, qualifications and responsibilities
Jan 13th – Session 2
• Laboratory controls, Test Procedures and Specifications
• Raw Material Testing
• Manufacturing Controls, Packaging and Labeling Controls
• Quality Control Department
• Packaging Material Testing
• Retain Samples
Jan 14th – Session 3
• Exercise – GMP regulatory observations
o Finished Product Testing
o Record Keeping
Jan 15th – Session 4
• Data integrity and documentation
• Supporting Quality Systems/Functions for GMP Compliance
o Outsourced activities
o Standard Operating Procedures (SOPs)
o Change control
o Product Complaints and Recall
o Annual product Review
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, labellers, 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 participate/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
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: 8 Jan 2021
|Basic Member:||$725.00||— Sold Out|
|Pro Pro Plus Ticket:||$625.00||— Sold Out|