Good Manufacturing Practices are regulations to ensure proper design, monitoring, and control of manufacturing processes and facilities. When the results of a process cannot be fully verified by inspection and testing, the process must be validated. In this course you will gain an understanding of the regulations requiring Process Validation and how they work within the quality system to insure that finished devices are safe and effective for their intended uses. Participants in this introductory course will also learn about Installation, Operational and Performance Qualifications (IQ, OQ, PQ), Process Monitoring, and strategies to correctly make changes or deviations in a process.
Participants in this course will learn:
• The importance of the FDA and regulating manufacturing processes and procedures
• FDA regulations for process validation
• The basics of IQ, OQ, and PQ
• An overview of process monitoring
• Strategies for changing processes and managing deviations
This course is available online, and can be taken anytime, anywhere.