Process Validation for the Pharmaceutical and Medical Device Industry
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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.