THIS EVENT HAS BEEN POSTPONED.
Last year, Health Canada released revised guidelines to the Good Manufacturing Practices (GMP) Regulations which became effective in October 2018. This course has been updated to include these changes.
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.
This 2-day course will cover the following topics:
- Introduction and Definitions
- Premises, Sanitation and Equipment-Personnel qualifications, training and responsibilities
- Developing a pharmaceutical quality system
- Testing, Raw materials and Vendor Qualification
- Manufacturing Controls
- Outsourced Activities
- Quality Control Department
- Packaging and Finished Product Testing
- Retain Samples and Stability
- Documentation, record keeping and Data Integrity
- Supporting quality systems elements (SOP’s, change control, deviations, non-conformance, product complaints and recalls, annual product review, self-inspection)
Who Should Attend
This is a good refresher course to ”get back to basics” for more seasoned personnel and for those wishing confirmation of their day to day GMP compliance activities. Those interested in the GMP updates and new employees to the pharmaceutical industry requiring GMP training would also benefit. Personnel from quality assurance, production, laboratories, regulatory affairs, distributors and wholesalers and auditors.
Dates: May 15 & 16, 2019
Time: 8:30 am - 4:00 pm
Location: Training Room 104, 1000 Waverley Street, Winnipeg
About The Instructor
Dr. Pauline McGregor, Ph.D. Chem, MRSC
Pauline has fulfilled a variety of roles in her thirty years in the pharmaceutical industry, including working with large Pharmaceutical corporations as well as contract testing laboratories in Canada and the UK. Pauline completed her honours degree and Ph.D. in photo organic chemistry in Scotland, where she also taught analytical techniques to undergraduate students. On completing her Ph.D. in 1995, she came to Canada to conclude her post-doctoral studies at the University of Western Ontario.
Pauline has taught analytical R&D, method validation, GMP and related Quality Systems courses across Canada, in the USA, Jordan and China. 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. Pauline is a member of The Royal Society of Chemistry, UK, is listed on the RSC Directory of Consultants. She is also on a USP Expert Committee for monograph review and on the USP Expert Panel for validation, verification and transfer of analytical procedures.