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The Center for Professional Advancement, New Brunswick, NJ
March 27-28, 2008
Who Should Attend
This course has been designed to benefit those in the Pharmaceutical industry with responsibilities related to the design, operation or management of the overall Quality System or any individual quality system used by the industry. The course is particularly suitable for personnel working in:- Site & Corporate Management
- Production
- Regulatory Affairs
- Pre-Market Departments
- Quality Units (including QA, QC & Quality Audit)
The course is applicable to personnel in API, commodity and outsource suppliers to the industry in addition to those in primary manufacturers of drug products.Description
The draft of ICH Q10 is the latest document that aims to define the requirements for a quality system for pharmaceutical operations. It discusses how the function of the system should evolve during pre-market operations, what its function is when a drug is marketed and how opportunities for product improvement should be identified and implemented throughout the product life cycle. The main element discussed in Q10 is what management, especially senior management, should be responsible for in assuring an effective Quality System. Other important elements receiving an emphasis in Q10 are the Quality System components such as change control, deviation control, CAPA, root cause determination, input/process/output monitoring, product reviews and documentation.
This course analyzes the content of Q10 and compares it with previous standards including the FDA Guidance on Quality Systems and ISO 9000. It analyzes its relationship with Q8 (Product Development) and Q9 (Risk Management) and the FDA Guidance on their Six-Systems Inspection Program and discusses the quality systems to which Q10 refers with particular reference as to how such systems can be effectively managed & integrated in accordance with Q10.
Throughout the course interactive discussion on this new, most important and far reaching Guideline will be encouraged.
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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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Alan J. Smith, Ph.D; Pharmaceutical Quality & Technology Consulting
Dr. Alan J. Smith is an independent consultant in pharmaceutical quality & technology. He was the Corporate Director of Quality Affairs for the Whitehall Division of American Home Products (now Wyeth) following a career with the Ayerst division. He received his B.Sc. & Ph.D degrees in Chemistry from the University of London (UK) & studied Business Administration at the Wharton School, University of Pennsylvania. He has had experience in analytical methods development, stability programming, regulatory affairs, quality control & corporate quality assurance. He is a member of the American Chemical Society & the American Society for Quality. He has been Chairman of many pharmaceutical conferences and also a member of several industrial association committees including the PMA (now PhRMA) committee on Stability & Expiration Dating & the ASTM committee on Quality Systems. He is a member of the Editorial Advisory Board of “Pharmaceutical Technology” & was the recipient of the 1998 WorldPharm award for service to the pharmaceutical industry. His consulting has included work with API and excipient manufacturers and firms under consent decree. He was a member of the Board of Directors of Halsey Pharmaceuticals 1994-2004.
John G. (Jerry) Lanese, Ph.D; President, The Lanese Group, Inc.
Dr. John G. (Jerry) Lanese is an independent consultant to the pharmaceutical industry. He received his Ph.D in Analytical Chemistry from the University of Michigan and his career has ranged from teaching in a small liberal arts college to working for pharmaceutical companies including Stiefel Laboratories, Bristol Laboratories, Carter Wallace, Inc., and Marion Merrell Dow. His experience has included managing Analytical Research, Quality Control & Quality Assurance functions and consulting for both pharmaceutical and medical device companies including firms under consent decree, API and excipient manufacturers and electronic firms.
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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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