Course Description:
Process validation is a meaningful scientific endeavour that strives to ensure process control and product quality rather than a discrete and isolated activity. According to FDA, process validation means establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications. Each manufacturer is required to establish and maintain procedures for monitoring and control of process parameters for validated processes to ensure that the specified requirements continue to be met. When changes or process deviations occur, the manufacturer is required to review and evaluate the process and perform revalidation where appropriate.
This workshop oriented seminar goes a step further. The most appropriate strategy is to eliminate the need for many validations by defect prevention strategies. When a process is not capable of producing a defect, it reduces the need to validate for such a defect. There are hundreds of defects that can be eliminated by changing the device design or changing the component design. This is a very powerful tool for gaining market share because it results in high device reliability at significantly lower cost.
Learning Objective:
- Learn to develop defect free processes
- Understand which tool to use depending on the device classification
- Avoid classic mistakes that waste time and produce ineffective results
- Learn the art of elegant problem solving
- Perform statistical analysis on process performance
- Learn when to re-validate and how
- Learn to minimize inspection and testing
- Stop using outdated and ineffective methods of root causes analysis
- Prevent manufacturing defects before they happen
- Discover that quality is free
- Help management in risk evaluation and decisions on marketing the product
- Capture new risks in new solutions
Who will Benefit:
This course is designed for all technical employees. This is particularly important for all managers because 85% device defects result from poor management practices according to Dr. Edward Deming, the world quality guru. Following personnel will benefit from the course:
- All senior managers
- Quality assurance supervisors
- Design engineers
- R&D engineers
- Production supervisors
- Quality professionals
- Regulatory professionals
- Compliance professionals
- Manufacturing engineers
- Production engineers
- Quality auditors
- Document control specialists