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 which result 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 conference by expert speaker Angela Bazigos will show the participant how to best achieve this to avoid adverse inspection results or harm to patients. The conference will also discuss the current cGMP requirements for the pharmaceutical supply chain and explain how to best implement them for successful inspections, and how to ensure that issues are addressed in a way that patient safety and good inspection results are preserved.
Who Should Attend
Angela Bazigos is the CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety, Turnarounds and Business Development. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers & Public Health Services companies. Positions include Chief Compliance Officer at Morf Media, Director of QA,...
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