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 the FDA’s expectations and the industry’s best practices.
Program Objectives
FDA and AAMI faculty work together to help the learner to:
– Determine which processes require validation and develop a Validation Master Plan
– Develop protocol content to ensure a successful validation
– Document the results and the resolution of deviations that occur during validation execution
– Plan for effectively monitors and controls for their validated processes
– Determine the re-validation requirements for product and process changes
– Planning, Protocol Development, Validation Execution, Monitoring & Control and Re-validation to meet the FDA’s expectation and industry’s best practices
– Demonstrate Return on Investment (ROI) to employers by completing and passing the Process Validation post-course test. This optional, one-hour, self-assessment tests your mastery of the course materials and your ability to correctly interpret the Quality System Regulation and ISO 13485 Standard.
For more information: https://aami.my.site.com/s/lt-event?id=a1YUW00000EsRft