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The Center for Professional Advancement, Amsterdam, The Netherlands
4-6 June 2008
Who Should Attend
This course has been designed for those who need to understand and improve their customer/supplier relationships. It is of particular interest to appropriate persons in- Corporate and Plant Management
- Purchasing
- Materials Management
- Scheduling
- Manufacturing
- Packaging
- Engineering
- Distribution
- Regulatory Affairs
- QA/QC
While the examples discussed are drawn mainly from the pharmaceutical industry, the material has applicability to other industries including the biological, device, diagnostics, and cosmetics industries. Description
From both a regulatory and business perspective, firms should partner with their suppliers (both vendors and contract suppliers) to assure that they receive materials and services according to predetermined specifications for quality, quantity and delivery. Some firms limit this activity to some degree of “qualification” while others extend it to “certification” or to some type of “strategic alliance.”
This course reviews the regulatory, legal and operational aspects including the role of the quality and operations functions. It includes a review of the techniques by which customers and suppliers can monitor one another via such techniques as statistical analysis and auditing. The FDA perspective, including the role and effect of FDA inspections, is reviewed and particular attention is given to the problems involved in contract work (i.e. outsourcing) with an emphasis on the need for carefully defining the respective responsibilities of the customer and supplier. The course includes a hands-on workshop in which mini-teams analyze case studies and present their findings.
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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 B.Sc. and Ph.D degrees 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 and Chairman of numerous pharmaceutical conferences. 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.
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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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