Center for Professional Innovation & Education, Inc., Los Angeles, CA
Dec. 13 & 14, 2012
This blended learning course includes online and classroom curriculum. The online portion is self-paced and represents an introductory prerequisite to the classroom session. This course is designed for Validation, Quality, IT, and business personnel responsible for implementing and using regulated computer systems in the pharmaceutical, biotech and medical device industries. Participants will gain a thorough understanding of computer system validation. In addition, the course will address how 21 CFR Part 11 (electronic record/electronic signature requirements) fits into the validation process. Course participants will be review expected content for computer validation deliverables through examination of example documents, as well as how to develop the validation rationale for a variety of circumstances.
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