Good Manufacturing Practices (GMP) were established by the pharmaceutical industry in the 60s and 70s as requirements for the manufacturing of food, drugs, and medical devices to ensure their quality and minimize risk to patients or consumers. Current Good Manufacturing Practices (cGMP) regulations require a quality management system, including documentation of each step of manufacture and analysis of potential risks to patients or consumers from adulterated or non-conforming products. It is further required that test results prove that the product is ready and acceptable to be distributed with little to no patient risk.
This session by expert speaker Jerry Dalfors will help manufacturers implement cGMP quality systems and risk management approaches during commercial operations and development, after the initial preclinical studies. Jerry will provide you expert advice on cGMP quality systems and risk management so that you’re able to meet FDA’s current good manufacturing practice (cGMP) regulation requirements. The program will explain how manufacturers can implement good manufacturing practices with quality management systems that are compliant with parts 210 and 211.
Who Should Attend
Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.
Mr. Jerry Dalfors has extensive (40+ years) of business administration, consultative, technical and managerial experience in the development and manufacture of highly regulated biopharmaceutical products including injectables, biologics, medical devices and oral dosages. He has held permanent employee, temporary employee and company representative management positions with a multitude of the major pharmaceutical and biotechnology companies in the US.