This webinar will examine the stated intent of the Agency to get tougher in its expectations for the medical industry, their supply chain, and vendor compliance to the cGMPs. It will examine how these goals of the Agency have translated into action over the past several years: The changing focus of QSIT re: medical devices, and ICH Q8, Q9, and Q10 re: pharmaceuticals; multi-site company operations, and the supply chain; The opening of 11 overseas FDA posts, Trends evident in 483 observations, Warning Letters, and recent major industry failures; Emphasis on proving a company is "in control" to an investigator's satisfaction regarding the integrity of its supply chain; and the negative role of "entropy". COA and COC, and venodr ranking models will be presented. The growing problem of medical product counterfeiting, and drug pedigrees will be discussed.

The regulated medical products industry is increasingly a global industry, with extended supply chains. Recent headlines indicate major supplier problems caused by weak oversight of such sources. Poor cGMP by vendors has resulted in major recalls and class action lawsuits. As a result, there has been a major shift in the emphasis of the U.S. FDA cGMP compliance audit, also affecting clinical trial expectations, product submissions and company response requirements. The public wants change. The U.S. FDA is responding. This change in focus has a major impact on interpretation of individual compliance objectives, cGMP objectives, and measurements of success, with a major focus on the source, control, and documentation of raw materials, components, and even services. The cGMP compliance audit, 510(k) submissions / data, "better science", outsourcing / globalization and supply chain / control issues, and drug pedigrees, requests for offshore supplier information from domestic manufacturers, and new offshore U.S. FDA offices, reflect this growing concern. They are all part of a new, tougher stance on the supply chain by the U.S. FDA.