Indian Rocks Beach, FL 33785
(727) 642-0182
(813) 774-8657
(727) 593-3595 FAX
"Helping People Learn Compliance and Science" SM
How To Implement A Current Good Manufacturing
Practices (CGMPs) Laboratory Audit System
ABOUT THE COURSE
"How To Implement A Current Good Manufacturing Practices (CGMPs) Laboratory Audit System" is a solid, one-day course focusing on the practical aspects of implementing a CGMP Laboratory Audit System. The course materials are based on FDA guidance documents and current best practices of the pharmaceutical industry. The course is heavily augmented with real world examples and provides numerous templates and tools recently developed and used by the instructors at client sites. This is an excellent starting point for QA and laboratory management to evaluate and upgrade their existing quality systems.
WHO SHOULD ATTEND
Laboratory and QA personnel who are actively involved in implementing and maintaining quality systems within CGMP laboratories will benefit from this course. It is also an excellent means to cross-train personnel from outside the laboratory on the critical aspects of laboratory compliance and operation.
COURSE OUTLINE
1. Overview of the Laboratory Control System Audit Process
2. Preparing for the Audit
3. Auditing and Data Capture
4. Organizing Data and Reporting the Results
5. Developing and Implementing a Corrective Action Plan
6. Developing and Implementing a Verification Plan
7. Developing and Implementing a Monitoring Plan
8. Tools Templates and Examples
9. Review of Selected References
10. Where to Get Help
11. Questions and Answers
ADMINISTRATION
The course is one day in length. Cost is $525 per person, with a five-student minimum for on-site presentation. Payment can be made by personal check, company check, purchase order, or by MasterCard, Visa, or American Express. Registration can be made on-line or via telephone.
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