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The Center for Professional Advancement, Amsterdam, The Netherlands
2-3 June 2008
Who Should Attend
Technical and managerial professionals involved with sterile products, clinical materials, drug development, cosmetics, aseptics, food and beverage, medical research and QC testing will all benefit from the rigorous and practical discussions of this intensive course. It will be especially beneficial to- Microbiologists
- Processing Engineers
- Manufacturing Personnel
- Quality Assurance Professionals
- Validation and Compliance Staff Members
Description
Although one of the most basic and long standing areas of pharmaceutical and FDA regulated manufacturing, “cleaning,” “sanitation,” or “environmental control” programs remain an essential part of cGMP compliance with numerous issues and potential problems such as effectiveness and safety of chemical agents, sterility or cleanliness requirements for supplies and cleaning tools, and methods selection and proper techniques for sampling and measuring viables and nonviables.
It is an ironic but accepted problem in this field that one of the major sources of contamination is the frequent sampling and measurement of contamination required by cGMPs. It is felt that, because the cleaning methods are predominantly manual, they can not be fully “validated.” In addition to a rigorous environmental monitoring program, worker technique and training are critical factors in process reliability.
This course will shed light on these important issues and offer pragmatic help to overcome obstacles that often stand in the way of consistent, cost effective, biodecontamination programs. Just as important, the course will provide valuable guidance on conforming to qualification and validation requirements including disinfectants, facility conformance, gowning and pass-through, environmental sampling plans, data collection and reporting and response/action plans.
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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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