All regulatory authorities expect pharmaceuticals, biopharmaceuticals, and medical device manufacturers to comply with GMP regulations. The function of GMP regulation is to guarantee reproducible production of unadulterated, safe products of consistent quality. Governments enforce compliance with GMP through comprehensive and exhaustive inspections of company sites. Non-compliance with GMP regulations is considered a serious offense and can lead to product recall, product seizure, facility closure, and criminal prosecution of company management and employees.
The third in our GMP series, this course takes an advanced look at global GMP and other international regulatory guidelines, policies, and expectations. The course recognizes the important role of various international regulatory standards, guidelines, and agreements. It examines in detail the latest international and FDA regulatory requirements, policies, procedures, and trends.
In addition, the course will provide detailed guidance on main issues surrounding GMP requirements for a biological product and cleanrooms. This includes case studies and practical exercises to help students develop, implement, and maintain various GMP and quality-related activities.