Process validation training activities with a product lifecycle management concept and the FDA risk management framework is critical for the medical device industry, because most of the device failures happen from inadequate processes and poor process control systems. Manufacturers of medical devices must meet the requirements of the Quality System regulation for medical devices (21 CFR part 820). The Quality System regulation at 21 CFR 820.5 states that “each manufacturer shall establish and maintain a quality system that is appropriate for the specific medical device manufactured
Proper quality control programs help to control or eliminate manufacturing defects. FDA also believes that incoming material and in-process control validations will assure high quality.
Why Should You Attend
Process validation means establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications. Too many processes and too many validations are likely to result in too much time and money wasted in addition to FDA warnings. This webinar teaches you how to minimize process controls and process validations.
Areas Covered in this Webinar
Who Will Benefit
Dev Raheja, MS,CSP, is an international Risk Management and Quality Assurance consultant for Healthcare, medical device, and aerospace industry for over 25 years. He applies evidence base safety techniques from a variety of industries to healthcare. He is a trainer, author of the books Safer Hospital Care, and Preventing Medical Device Recalls. He shows clients how to come up with elegant solutions using creativity and innovation. He helped a major Midwest company from going out of business to becoming a world leader by eliminating safety mishaps. Prior to becoming a consultant in 1982 he worked at GE Healthcare as Supervisor of Quality Assurance and Manager of Manufacturing, and at Booz-Allen & Hamilton as Risk Management consultant for nuclear and mass transportation industry.
Currently he is an Adjunct Professor at the Florida Tech for its degree in Healthcare Management, and serves on the Patients and Families Advisory Council at Johns Hopkins Hospital. He is Associate Editor for Healthcare Safety for the Journal of System Safety, and is a member of the American College of Healthcare Executives.View all trainings by this speaker