Who Should Attend
This practical course is intended for professionals in the pharmaceutical, cosmetic and related industries, including:
• QC and Operations Supervisors
• Investigation Writers
• Laboratory Analysts
It is most beneficial to manufacturing personnel involved in:
• Clinical packaging
• Manufacturing
• Lab testing
Higher level technical and managerial personnel will find the course a worthwhile refresher of the basics and interpretive aspects of the regulations.
Description
This course will provide an orientation and understanding of the Current Good Manufacturing Practice segment of the U.S. Food, Drug, and Cosmetic Act. The course will cover supervisory techniques and practices for complying with the U.S. FDA regulations in packaging, assembly, production and manufacturing. It will provide a practical application of the cGMP on the operating level. Actual experiences and case studies will be included. Ample time will be given to the specific problems of participants. This course will prepare firstline supervisors and other plant manufacturing personnel to successfully discharge their responsibility for implementing a company's cGMP program.