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.

Webinar on 21 CFR Part 11 - Road to Successful FDA Compliance

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.

Regulatory authorities act as a guardian that ensures the safety, efficacy and quality of drugs available to the public, to identify the strengths and weaknesses of drug regulation and to propose strategies to improve drug regulation.