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The Center for Professional Advancement, Den Haag, The Netherlands
28-30 May 2008
Who Should Attend
This course is intended for professionals in:- Process Engineering
- Production
- Quality Assurance
- Validation
- Technical and management positions
You should have some familiarity and experience with the basic subject as it applies to research and manufacturing of pharmaceuticals, personal care products, nutritional materials and fine chemicals. Description
This course will provide a solid overview of the principles and practices of residue removal and residue measurement on product contact surfaces. It will address the latest issues, industry practices and compliance strategies regarding choice of cleaning techniques, cleaning agents, analytical methods, residue challenges, grouping strategies and validation protocols. Examples and case histories will be presented. Recent regulatory expectations and guidance from US and Europe will be discussed in depth.
For participants experienced on this subject, this practical course will help to better audit, evaluate and develop their own or third party cleaning programs to balance production objectives against QA/validation objectives. The idea is to first achieve an effective, reliable cleaning process defined parametrically, then generate sufficient data without going overboard on the number of samples, the number of analytical tests and the number of qualification studies that have become an excessive burden to many firms.
Participants are encouraged to bring a cleaning problem to the course for evaluation by participant teams or for inclusion in “Participant Problem Clinic” on the second day.
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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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Steven A. Weitzel; Technical Director, Critical Process Cleaning, Inc.
Mr. Steven A. Weitzel is Technical Director for Critical Process Cleaning, Inc. Previously, he held technical and management positions at Novaflux Technologies, Bristol- Myers Squibb, Calgon Vestal/Merck, Mallinckrodt, Dow and Princeton BioGroup with experience in engineering, manufacturing and validation of medical devices and in-vitro diagnostics, bulk compounds, oral dosage products, terminally sterilized and aseptic parenterals. He is a frequent industry speaker and is consulted regarding process cleaning, validation and environmental control.
Mr. Weitzel holds a B.S. degree in Chemical Engineering from the University of Missouri, Columbia and an MBA from Washington University. He is a member of the ISPE and the PDA.
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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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