Applied cGMPs for Pharmaceutical and Allied Industries
This course is not currently scheduled. Click on the Notify Me button to the left to be notified when it is scheduled.
This course is available as a client site course. Please click here for more information.
Who Should Attend
This is an ideal course to acquire current applications of
cGMPs. It offers latitude for discussion of fundamental as
well as evolving regulatory initiatives and other complex
issues. The course is distinguished for benefit to domestic as
well as non-US enterprises, including the following:
Positions
Analysts, Directors, Engineers, Executives, Investigators,
Internal Auditors, Managers, Operators, QA/QC, Research,
Supervisors, and Trainers
Industries
Academia, Biogeneric, Biological, Biopharmaceutical,
Combination Product Manufacturers, Consultants, Contract
Manufacturing, Dietary Supplements, Health Care, Legal
Pharmaceutical. Regulatory, and Many Others…
Description
This course takes you through Current Good Manufacturing
Practice (cGMP) in the pharmaceutical and allied industries.
Topics covered include legal requirement for cGMP in the
Federal Food, Drug, and Cosmetic Act and related
regulations. It addresses practical aspects of personnel,
facilities, equipment, components, manufacturing, laboratory,
packaging, labeling and QA/QC and provides an excellent
forum for training personnel in cGMPs. The faculty consists
of individuals with long and distinguished experience in the
field. Throughout this course, the relevance of FDA
inspections commonly surfaces. There is special emphasis on
discussing procedures and practices of the regulatory agency
to help firms comprehend management of FDA relationships.