The third in our GMP series, this course takes an advance 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 such as ISO 9000 series, SUPAC, ICH, and MRA. It examines in detail the latest international and FDA’s regulatory requirements, policies, procedures and trends.
Regulatory authorities have always been in favor of internal and external audit programs and have issued citations to companies for failing to conduct audits.
The course uses variety of methods from theory to practical workshops to give students a solid knowledge of regulatory requirements and quality standards as well as the ability to carry out in-depth audits of quality systems in the pharmaceutical industry.