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The Center for Professional Advancement, New Brunswick, NJ
January 31-February 1, 2008
Who Should Attend
This course should benefit those who need to know how APRs for drug products and/or active pharmaceutical ingredients should be designed, organized and otherwise managed. The course will benefit individuals in:- Quality Assurance
- Quality Control
- Regulatory Affairs
- Production
- Technical Services
- Site & Corporate Management
It should also be of interest to suppliers to the industryDescription
The FDA’s cGMP regulations require that an annual review (commonly called “Annual Product Review”) be performed for all drug products. The EU GMP regulations and also the ICH Q7A guideline for the GMP’s for active pharmaceutical ingredients have corresponding detailed requirements. In each case, there is a general requirement that the quality of each product be reviewed at least once per year “to determine the need for changes in specifications or manufacturing or control procedures” and that any adverse or unexpected trends be identified so that corrective action can be taken. It is indicated that the review should encompass “a representative number of batches” and include considerations of “recalls,” “product complaints,“ “returned & salvaged products” and“investigations” performed as a result of deviations encountered during production. The wording used is very broad and provides little guidance on what details should be addressed. This course sets out to define what details should not only satisfy the FDA’s expectations but should also help meet the firms economic goals of understanding product quality & identifying areas for correction & improvement. The course includes a consideration of the system by which APRs can be effectively and efficiently prepared and issued as well as the details which the SOP should address.
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Organized by:
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The Center for Professional Advancement |
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Invited Speakers:
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Dr. Alan J. Smith; Pharmaceutical Quality and Technology Consultant
Dr. Alan J. Smith is a consultant specializing in pharmaceutical quality and technology. He was formerly the Corporate Director of Quality Affairs for the Whitehall Laboratories Division of American Home Products Corporation (now Wyeth) following a career with the Ayerst Division. He received his Ph.D degree from the University of London in the UK and also studied Business Administration at the Wharton School of the University of Pennsylvania. He has had experience in both the chemical and pharmaceutical industries in research, analytical methods development, stability programming, regulatory affairs, quality control and corporate quality assurance. He is a member of the American Chemical Society & the American Society for Quality. He has been President of the Montreal Pharmaceutical Discussion Group. He has been a member of several industrial association committees, including the PMA (now PhRMA) Committee on Stability and Expiration Dating and the ASTM Committee on Quality Systems. Dr. Smith is a member of the Editorial Advisory Board of the journal “Pharmaceutical Technology”. He was the recipient of the 1998 WorldPharm Award for services to the pharmaceutical industry. His consulting has included work with firms under consent decree.
Dr. John G. (Jerry) Lanese; President, The Lanese Group, Inc.
Dr. John G. (Jerry) Lanese is President of the Lanese Group Inc., a consulting organization specializing in quality systems with a special emphasis on Management and Laboratory operations. He received his Ph.D in Analytical Chemistry from the University of Michigan. He is a Certified Management Consultant and an assessor for ISO 17025 registration. Dr Lanese is a member of the American Society for Quality, the Institute of Management Consultants, AOAC and the American Association of Laboratory Accreditation. He is a member of the Editorial Advisory Board for The Journal of Validation Technology and was a member of the PMA (now PhRMA) committee on Computer System Validation.
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Deadline for Abstracts:
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n/a
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Registration:
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Please click here for registration information.
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E-mail:
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info@cfpa.com
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