Good Manufacturing Practices are critical to everyday operations in the pharmaceutical industry. The basic principles of GMP are to assure the quality, potency, identity, safety and purity of products and to protect both the consumer and the company. This 2-day course provides a refresher of Good Manufacturing Practices based on current Health Canada guidelines. In 2017 Health Canada issued proposed updates to GUI-001 with a view to harmonize it with global GMP standards. This course has been updated to include the proposed changes. It bridges the gap between the black and white regulations and everyday operations by describing the regulations and the practical application of them through key quality system elements, essential to GMP compliance. The course material is presented by means of slides, handouts and participation of the attendees through discussion and group exercises. 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
- – Summary of proposed changes for 2017
- -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 proposed 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.
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 PhD in photo organic chemistry in Scotland, where she also taught analytical techniques to undergraduate students. On completing her PhD 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 harmonised 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.
Registration Deadline: 12 Jul 2017
|Student Ticket:||$480.00||— On Sale||Until: 16/07/17 3:55 AM|
|Pro Ticket:||$910.00||— On Sale||Until: 16/07/17 3:55 AM|
|Basic Ticket:||$960.00||— On Sale||Until: 16/07/17 3:55 AM|