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The Center for Professional Advancement, Amsterdam, The Netherlands
8-9 May 2008
Who Should Attend
This course is designed for pharmaceutical and related industry personnel who participate in acquiring and preparing data related to the sterilization technology section of regulatory filings to the FDA. It is best suited for supervisors, managers, and directors in many disciplines including:- Quality Assurance
- Engineering
- Production
- Regulatory Affairs
- Microbiology
This course may also be useful to management personnel that wish to understand the requirements of sterilization process validation documentation essential to regulatory agencies Description
This course will include discussion on topics such as container/closure integrity testing, product stability studies, engineering heat penetration and distribution studies, container thermal mapping, and environment control programs. In addition to an overview of moist heat sterilization, and FDA requirements, the attendees will participate in the resolution of proposed case studies, and perform data calculations and graphing exercises to assure a practical understanding of the sterilization principles and procedures that will be discussed. Discussions on how moist heat sterilization is employed during aseptic processing, and the requirements for moist heat sterilization of aseptic processing equipment and product components will also be presented. Emerging regulatory positions in the USA, and Europe regarding moist heat sterilization will be summarized.
On the final day, the course allows for interactive time to clarify issues, topics, or offer suggestions regarding actual situations that the attendees may be encountering.
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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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Jeanne Moldenhauer; Pharmaceutical Consultant, Vectech Pharmaceutical Consultants, Inc.
Dr. Jeanne Moldenhauer, Pharmaceutical Consultant at Vectech Pharmaceutical Consultants, Inc., is a senior quality assurance/regulatory affairs professional with an extensive background in the development and management of a variety of sterilization and validation processes in the healthcare industry.
Ms. Moldenhauer is the editor and co-author of “Steam Sterilization – A Practitioner’s Guide”, published by PDA/DHI in 2003, and her latest book, “Environmental Monitoring and Laboratory Validation” is due out in 2005. With over 30 years experience in the healthcare and pharmaceutical industries, she has authored over 19 publications and has extensive experience in presenting at seminars and training courses.
Ms. Moldenhauer is a Technical Council member and interest group leader for the Parenteral Drug Association (PDA), and serves as the founder and chair of The Rapid Micro Users Group (RMUG).
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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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