Gain solutions to your company's immediate goals to lower production costs, improve process efficiency, increase production quality and meet regulatory requirements.
Join us as we take a deep dive into critical areas of pharmaceutical manufacturing at the ISPE Bethesda Training Facility located at 6110 Executive Blvd, Suite 600, North Bethesda, MD 20852.
This classroom course examines current technology and provides scenario-based exercises for system troubleshooting and investigational events for process deviations, discusses quality management and GMP inspection preparation, and provides guidance on advanced asset lifecycle management strategy.
Jack Chu has more than (30) years business experiences in Bio-pharm and Life Sciences Industries. After about (25) year services at Merck, Jack joined CAI (Commissioning Agents, Inc.) as Senior Consultant in 2017. Jack Chu is a licensed Professional Engineer. He has designed and implemented many significant projects worldwide since 1985. Jack also successfully led professional teams as expert witness for many complicated legal cases relating to engineering, technology, and operational issues.
This GAMP 5 GxP Process Control Training Course describes how the GAMP® Good Practice Guide: A Risk Based Approach to GxP Process Control Systems, may be applied to achieve process control systems that are fit for intended use and meet current regulatory requirements.
John Hannon is an Executive Consultant and Business Area Leader for Automation and IT at Commissioning Agents. With over 27 years in the pharmaceutical, IT, and process automation fields, he has been instrumental in starting up cutting-edge biotech facilities for companies such as Baxter, Monsanto, Amgen, Genentech, Wyeth, and Cook. In the past, he has managed multi-million dollar projects along with dozens of client managers across the Southeastern US, responsible for delivering hundreds of high-profile, mission-critical projects for biotech, pharmaceutical, and medical device customers.