The U.S. Food and Drug Administration (FDA) launched a major initiative to modernize the regulation of drug manufacturing and product quality in 2002. This program calls for the application of modern risk and quality management techniques, the use of engineering knowledge and new manufacturing technologies and the application and demonstration of cutting-edge science throughout the entire production process.

Driven by the increase in the number of adverse events and drug recalls in recent years, FDA has changed its method of monitoring drug manufacturing. They introduced systems thinking, quality by design and related processes that assure the quality of any product in manufacturing. This resulted in a new FDA initiative 'Good Manufacturing Practices (GMP's) for the 21st century'. The initiative requires pharmaceutical companies to comprehensively manage patient risk, base new drug submissions and manufacturing approaches on demonstrable scientific principles, and simultaneously implement inspection-ready 'GMP Systems' which embed compliance and quality in their operations. Of particular significance is the risk transfer among products resulting from the new approach of GMP Systems inspections. All products produced at a facility may be considered 'adulterated' if any one GMP system fails inspection. It is possible that a single low-revenue high-risk product may wipe out an entire facility's revenue. The assets and infrastructure of pharmaceutical companies were designed to meet the 25-year old GMP regulations and are now exposed to the new risks brought up by the FDA programs related to quality by design.

One of the practical implications of the FDA's challenge is the restructuring of a company's supply chain. A company will need to manage its risks across products, technologies, and sites, and ensure that its drugs are safe at the point-of-use. This webinar will show the participant how to best achieve this to avoid adverse inspection results or harm to patients.