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  • Stop using outdated and ineffective methods of root causes analysis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

Course Outline:

Day 1 (8:30 AM – 4:30 PM) Day 2 (8:30 AM – 4:30 PM)
  • 8:30 – 9:00 AM: Registration
  • 9:00 AM: Session Start Time
  1. Theory of process validation
    1. Process design
    2. Process qualification
    3. Continued process verification
  2. Requirements are not prescriptive
  3. Mistakes to avoid in process validation
  4. Making sound, science-based process improvements
  5. Using an integrated approach to product quality
  6. Risk improvement tools
    1. Pareto analysis
    2. X-bar and R charts
    3. I-MR charts
    4. Normal distribution graphical method
    5. Analysis of variance
    6. Correlation diagrams
  7. Workshops on Control charts
    1. X-bar and R chart
    2. Moving range chart
  8. Regulatory expectations
    1. Current good manufacturing practice
    2. CFR part 210, and 211
  9. Life cycle activities that manufacturers carry out
    1. Controlling variation
    2. Using statistical tools
    3. Role of management
  10. Workshop on statistical tool
  11. validating processes that cannot be fully verified
  1. Process defect prevention strategies
    1. Preventing defects through component/assembly re-design
    2. Preventing defects by choosing robust processes
  2. Workshop on defect prevention
  3. Developing process validation protocol
  4. Installation qualification (IQ)
  5. Operational qualification (OQ)
  6. Performance qualification (PQ)
  7. Validating software for manufacturing processes
  8. Developing in-process specifications
    1. Conducting Process FMEA proactively
    2. Using evidence based statistical data from good processes
  9. Sampling methodologies
    1. Random sampling
    2. Sampling when population size is small
  10. Calculating process capability
    1. One sided capability
    2. Two sided capability
  11. Workshop on process capability
  12. Corrective and preventive actions
  13. Purchasing controls
  14. Final acceptance activities
  15. Managing non-conforming products
  16. Managing complaint files
  17. Management responsibility
  18. Quality audits
  19. Training

Meet Your Instructor:

Dev Raheja
Author of the books Safer Hospital Care and Preventing Medical Device Recalls

Dev Raheja, MS,CSP, author of the books Preventing Medical Device Recalls and Safer Hospital Care, is an international risk management, patient safety and quality assurance consultant for medical device, healthcare and aerospace industry for over 25 years. Prior to becoming a consultant in 1982 he worked at GE Healthcare as Supervisor of Quality Assurance/Manager of Manufacturing Engineering, at Cooper Industries as Chief Engineer, and at Booz-Allen & Hamilton as Risk Management consultant for variety of industries. His clients include Johnson & Johnson, Siemens Medical Systems, Medtronic, Carl Zeiss, Warner-Lambert, Zimmer Holdings, and DuPont. He has served as Adjunct Professor at the University of Maryland for five years for its PhD program in Reliability Engineering. He is a Fellow of American Society for Quality and recipient of its Austin Bonis Award for Reliability Education Advancement, former chair of the Reliability Division, and member of the Biomedical Division. He is a Senior Member of IEEE. Currently he is an Adjunct Professor at the Florida Tech for its BBA degree in Healthcare Management, has authored two more books Assurance Technologies Principles and Practices, and Zen and the Art of Breakthrough Quality Management. He has received several industry awards including the Scientific Achievement Award and Educator-of-the Year Award from System Safety Society. He is a former National Malcolm Baldrige Quality Award Examiner in the first batch of examiners. He serves on the Patient and Families Advisory Council at Johns Hopkins Hospital and is a member of American College of Healthcare Executives.

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