Monthly Archives: March 2024

This 3-day course provides attendees with practical tools and techniques for process validation requirements for FDA’s Quality System Regulation and recognized process validation guidance from the Global Harmonization Task Force. The program includes industry best practices and real-life process validation examples. Topics include planning, protocol development, validation execution, monitoring & control and re-validation to meet [...]

During this 3-day training, learn how to develop and validate medical device software in an ever-changing landscape of regulations and technology. This class will ground you in all the relevant regulations, standards and guidance and help you understand how risk, cybersecurity, cloud computing and mobile apps impact the medical device software space.  It will also [...]