Thursday September 2, 2010 Thursday September 2, 2010
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Good Manufacturing Practices (GMPs) are regulations that describe the methods, equipment, facilities, and controls required for producing safe and effective pharmaceutical and biotech products.
Regulators expect the companies to have continuous training program in place and to demonstrate the effectiveness of the training delivered. Non-compliance with GMPs can be expensive, time-consuming and can result in FDA regulatory action imposed against your firm..
This one and a half a day refresher training course presents an overview of the framework and principles of GMPs, by reviewing the background and history of GMPs and defining roles and responsibilities of those affected by the requirements. In addition, this course provides insights on how to design a GMP-compliant system, and how best to comply with requirements governing component control, warehousing, storage and distribution operations. In completion of this participants will be able to implement proven validation solutions and identify current regulatory enforcement trends. They will also be able to evaluate proven strategies for implementing GMPs in preparation for an FDA inspection.
Mr. Timothy J. Fields
President
Drumbeat Dimensions, Inc.
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Mr. Fields has over 25 years of experience in the pharmaceutical industry including 13 years with Pfizer where he was responsible for organizing and managing the corporate software quality assurance audit program, developing GMP training programs for management level personnel, and conducting numerous internal and external quality audits.
Mr. Fields has experience in a variety of compliance areas including sterilization validation, aseptic processing, computerized system validation, process validation, cleaning validation, GMP training, 21CFR Part 11, document management, calibration, and auditing.
Mr. Fields is a member of the International Society of Pharmaceutical Engineers (ISPE), Parenteral Drug Association (PDA), and GAMP Americas. He has published and lectured worldwide on various compliance-related topics including computer-related system validation, electronic signatures and records, document management, validation, and GMPs.
Mr. Fields has a B.A. in Biology from Indiana. Furthermore, he is a member of the Editorial Review Board for the Journal of GXP Compliance as well as an adjunct instructor at the Community College of Rhode Island, where he teaches “Introduction to Pharmaceutical Compliance”.
Requirements for Storage and Distribution Operations
Group Exercise - GMP regulatory observations and how they could have been avoided
Interactive Group Exercise
Registration Fee Includes: Presentation Materials, Luncheon, and Refreshments
Cancellation/Substitutions Policy: CANCELLATION POLICY: Cancellation is accepted in writing (by mail, or fax) up to 4 weeks before the program start date, after which cancellations are not accepted and do not qualify for refund or credit. All Cancellations are subject to a $210.00 CAD (incl. GST)/person processing fee. Substitution of delegate/s with the member/s of the same organization is permitted at any time. IPA reserves the right to postpone an event, prior to which time all the registered attendees will be notified a minimum of 2 weeks in advance. IPA shall not be responsible for any air fare, hotel or transportation costs incurred by registrant/s.
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Hotel Accommodation Tel: 416 -493-9000 or |
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A special room rate has been prearranged for conference participants. Call the hotel directly at the above number and mention IPA to receive the reduced room rate. For more information, please call us at 416-410-7402 or enquiry@ipacanada.com |
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