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Course

MONTREAL

Date:	Name:	Location
Tuesday, February 16, 2010 9:00 AM TO 4:00 PM ON DAY 1 9:00 AM TO 3:00 PM ON DAY 2 (Registration 8:30 AM ON DAY 1)	NEW DATE! The Annual Product Review: Creating and Optimizing your APQR Process to meet Regulatory and Business Objectives 2-DAY COURSE ONLY 4 SPOTS LEFT!-Please call 905-513-7743 to register	Plaza Volare (in the Crowne Plaza Hotel) 6600 Cote-de-Liesse Saint-Laurent, QUEBEC 514-735-5150 Room: Oslo
Fees:	Registration Link:	Registration Deadline
PSG Member: $560.00 + $28.00GST = $588.00 Non-Member: $680.00 + $34.00GST = $714.00	Registration for this course is currently closed.	Thursday, February 11, 2010
Course Objective:
FEBRUARY 16 & 17 We are sorry, but we are not able to offer this course in French and apologize for any inconvenience. The Annual Product Review (APR) originated in 1978 with the the US Food & Drug Act, 21 CFR Part 211 and it applied to companies that manufactured, imported or distributed pharmaceutical product in the USA market. The regulation often was not well understood and questions asked included: How much data should I collect? When should I use statistical trending? How should I present the data? Who is really responsible for creating the report? How best can I involve my suppliers? And so on. It seemed that completing the APR report was often a low priority for many firms, and there were few resources allocated to the task. With the emergence of new EU and Health Canada requirements for APR/APQR reporting (including the new Health Canada 2009 GMPs, expected in Nov 2009), the requirement for an effective, efficient and compliant APR process has become increasingly urgent and important in the pharmaceutical industry.
Course Description:
This interactive, 2-day lecture/workshop format will provide a comprehensive review of regulatory agency requirements and expectations for APR reporting, as well as practical approaches to establish and optimize the APR process in your company. The intent is that the APR report goes beyond mere regulatory compliance and achieves the real benefit intended, i.e. meaningful improvement of product quality, manufacturing processes and quality system performance by conducting an annual, thorough review of all data associated with a product, from raw material to finished product stage, with recommendations for product improvement presented to corporate senior management. Topics covered include: Overview of the Regulatory Requirements for APR (FDA, Health Canada, EU and ICH) The new Health Canada 2009 GMP regulations for APQR Purpose and Benefits of APR Effective Policies, Procedures and Work Flows Assigning Responsibility across the Organization (QA, QC, RA, Mfg, Suppliers) Supplier involvement and Resource allocation Data Collection and Analysis - Trending Strategies Detailed Review of each APR reporting section Efficient Report Preparation, Review and Approval Recommendations for Senior Management action Other Considerations (Technology Applications, RCA, Costs & Training, Process Improvement)
Course Leader:
Michael Lopez, B.Sc., MBA Michael recently took on the leadership position of Manager of Quality Operations at EMD Canada. He also owns his own consulting company, Quality Systems M+D Inc. (QSM+D), a Canadian company that audits, designs, implements and provides training on Quality Systems and software applications for the pharmaceutical and related industries: manufacturers, importers and distributors. Michael has over 20 years of Product Development and QA/QC experience with Sanofi Pasteur (Aventis), Pfizer (Warner-Lambert) and SmithKline Beecham (GSK) and is an active member of the National PSG (Canada) and the Parenteral Drug Association (USA). His passion is for building and optimizing Quality Systems (policies, procedures, resourcing) and his expertise includes APR, CAPA, Complaints Management, Change Control, GMP Auditing and Quality Metrics Trending. For the past eight years, Michael has provided training on APR and CAPA quality systems to the Canadian and USA pharmaceutical industry. Michael has his B.Sc. in Biochemistry from the Univ. of Toronto and his MBA from the Ivey School of Business, Univ. of Western Ontario.
Who Should Attend:
This two-day course is designed for QA, QC, Mfg, Technical Support and RA professionals who are involved in the APR process, i.e. product testing, process monitoring, data collection, analysis, trending and report preparation for management and Agency review. This course is also a good refresher for those Managers and professionals who desire fresh ideas to optimize their APR process, i.e. improve contributor accountability, reduce preparation timelines and improve implementation of recommendations to meet quality improvement and compliance objectives. ***PSG reserves the right to modify the material or instructors without notice or cancel an event. If the event must be cancelled, registrants will be notified as soon as possible and will receive a full refund of fees paid. PSG cannot be responsible for discount airfare penalties or other costs incurred due to a cancellation.

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