Tougher Supplier Controls – Avoid Unwanted Changes
September 26, 2018 - Online Event ON CAWebinar Compliance
info@webinarcompliance.com
Phone:416-915-4438\58
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.