The Center for Professional Advancement, New Brunswick, NJ
March 10-11, 2008
Who Should Attend
This course is intended for professionals involved in the pharmaceutical and related industries, including, but not limited to:- Quality Assurance
- Quality Control
- Production
- Regulatory
- Engineering
- Research and Development, and software
- Process Design and Development
Description
Validation of manufacturing processes in the cGMP environment is recognized by the medical manufacturing industries and by the regulatory agencies in the U.S., E.U. and Japan. This course will give the attendee an overview and understanding of the validation process, how to organize it and carry out process validations, key areas to look for during an audit, and assist managers in overall planning.
Various approaches to validation will be discussed with actual examples of successes and failures of industry validation experiences.
Participants are invited to bring examples of their own validation issues to be discussed during the case studies session.
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