If you conduct process validation, you need to ensure that your results are valid. Beyond the regulatory requirements, statistical approaches will help you achieve the desired result - processes that produce only conforming material.
This Video provides an overview of the FDA's Drug Development Process. This webinar also includes the major FDA regulations involved in the Drug Development Process - the GLP, GMP and GCP regulations.
The U.S. Food and Drug Administration has a lot of regulations that companies must obey to sell products that are safe for the public to consume. James Shores explains the ways that manufacturers can stay FDA compliant in this video.
Are there any differences in terms of compliance issues cross-country (or even regions)? Yes and no. In general, there are only minor differences in GMP. However, speaking of auditing, differences
almost always exist.
Carpenter, author of Reputation and Power:Organizational Image and Pharmaceutical Regulation at the FDA will join us to discuss the FDA and the pharmaceutical industry.
Martin Lush, Global Vice President of NSF Pharma Biotech and Medical Devices, gives his insights on how companies can go about changing GMP behaviors and in doing so change quality culture.