Good Manufacturing Practices are critical to every day 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 and FDA guidelines. It includes the new requirements described in GUI-0001 version 2 which was released in 2011 by Health Canada as well as emphasizing the key changes brought about in the original version in 2009. 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
- Global GMP, including the new 2011 Health Canada GMPs
Premises and Equipment
- Personnel hygiene, training and responsibilities
- Quality Assurance versus Quality Control
- Manufacturing Controls
- Packaging and Labelling
- 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. New employees to the pharmaceutical industry requiring GMP training would also benefit. Personnel from Quality Assurance, Production, Laboratory personnel, 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.
|Basic Member:||$300.00||— Sold Out|
|Basic Member Group Tickets:||$200.00||— Sold Out|
|Student Ticket:||$250.00||— Sold Out|
|Pro Ticket:||$150.00||— Sold Out|
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