cGMP Regulations for Pharmaceutical Corporate Executives
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 program is designed for those charged with executive management responsibility, including allocation of resources within the company, and who have to decide how to implement and pay for cGMP compliance. Such individuals include presidents and CEOs of medium and small pharmaceutical companies, corporate counsels not specifically experienced in FDA matters, vice presidents and directors of operations, purchasing, marketing and sales of companies producing bulk and finished human and veterinary pharmaceuticals under FDA requirements contained in 21 CFR Parts 210 and 211.
Technologists, line management and supervisory personnel desiring cGMP courses are directed to other Center for Professional Advancement programs.
Description
Current Good Manufacturing Practice (cGMP) Regulations for Pharmaceutical Corporate Executives is offered by The Center to afford human and veterinary drug company corporate executives the opportunity to acquire an understanding of today’s requirements and the rationale for cGMP regulations. The cost of being in compliance, especially after an FDA inspection, can be significant. “It’s cheaper to do it right” before the FDA investigator arrives. This suggests that corporate executives be knowledgeable about cGMP regulations to make better informed decisions about implementing and paying for cGMP compliance.
Topics covered will include not only the legal requirements for cGMP in the Federal Food, Drug, and Cosmetic Act, but also the implementation of cGMP regulations in purchasing, manufacturing, packaging, labeling and QA/QC, as well as training personnel in cGMP.