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Course

Toronto

Date:	Name:	Location
Wednesday, April 21, 2010 9:00 AM TO 4:30 PM (Registration 8:30 AM)	Working in a GMP Environment - 11th Session!	PSG Office 3780 14th Avenue, Suite 210 Markham, ON 905-513-7743
Fees:	Registration Link:	Registration Deadline
PSG Member: $590.00 + $29.50GST = $619.50 Non-Member: $750.00 + $37.50GST = $787.50	Registration for this course is currently closed.	Wednesday, April 14, 2010
Course Objective:
Two-Day Course, April 21 & 22, 2010 - LIMITED SPACE AVAILABLE! PLEASE REGISTER ASAP TO GUARANTEE A SPOT! 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, including the new requirements contained in the 2009 Health Canada GMPs. 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.
Course Description:
This 2-day course will cover the following topics: Introduction and Definitions Global GMP, incl. the new 2009 Health Canada GMPs Premises and Equipment Personnel hygiene, training and responsibilities Quality Assurance versus Quality Control Manufacturing Controls Packaging and Labeling Good manufacturing practices in the laboratory Documentation Supporting quality Systems elements (SOP’s, Change Control, Deviations, non conformance, Product complaints and recalls, Annual Product review, Self inspection)
Course Leader:
Pauline McGregor, Ph.D. Chem, MRSC Pauline has fulfilled a variety of roles in her twenty 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 complete 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 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 and frequently writes and reviews articles on current industry topics.
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.

Health Canada/Santé Canada • U.S. Pharmacopeia (USP)
Canadian Association of Professional Regulatory Affairs/Association canadienne des professionnels en réglementation (CAPRA/ACPR)