Center for Professional Innovation & Education, Inc., Los Angeles, CA
Aug. 18 – 20, 2014
This course will provide the participant knowledge of current GMPs, how they are applied in the Bio/Pharmaceutical market today, and how they will be enforced in the future. Topics included are: - Impact of facility and equipment design on GMP compliance
- Risk management approach to compliance
- Vendors
- Commissioning, Qualification and Validation – Which one to use
- Problem resolution
- Part 11 in production and the laboratory
A comparison between 21 CFR 210/211, 600, and 810 as well as ICH guidelines will be made as they affect combination products, normal Bio/Pharmaceuticals, and Medical Devices. Current "hot" topics and examples of recent warning letters will also be discussed and evaluated. This course has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for 12 credits towards a participant's RAC recertification upon full completion.
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