Indian Rocks Beach, FL 33785
(727) 642-0182
(813) 774-8657
(727) 593-3595 FAX
"Helping People Learn Compliance and Science" SM
Overview Of The Current Good Manufacturing
Practices (CGMPs) Regulations
ABOUT THE COURSE
“Overview of the Current Good Manufacturing Practice (CGMP) Regulations” is a solid, one-day, survey-type course based on FDA’s newly adopted quality systems based approach for auditing CGMP facilities. The course materials are based on internal FDA guidance documents and current best practices of the pharmaceutical industry. The course is augmented with real world examples recently encountered by the instructors. This is an excellent means to introduce new personnel, regardless of their specialization to the concepts of current good manufacturing practices in general.
WHO SHOULD ATTEND
All newly hired manufacturing, QA, or laboratory personnel who are preparing to work in a CGMP regulated environment. Also, personnel not directly involved in the manufacturer, testing, and release of products but work in organizations who execute these functions will also benefit from this course.COURSE OUTLINE
1. Overview of the Pharmaceutical Industry and the Drug Development Process
2. The Law and FDA’s Role in the Drug Development Process
3. Definition of Current Good Manufacturing Practices
4. Introduction to the Systems Based Approach to CGMPs
a. The Quality System
b. The Facilities and Equipment System
c. The Materials System
d. The Production System
e. The Packaging and Labeling System
f. The Laboratory Control System
5. The Consequences of Not Complying with CGMPs
6. Summary
7. Questions and Answers
8. Resources
ADMINISTRATION
The course is one day in length. Cost is $525 per person, with a ten-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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