Process Validation for Medical Device Manufacturers

Why Should You Attend:

The US FDA has required medical device manufacturers to validate certain production processes since the 1980's. Recently the Center for Devices and Radiological Health (CDRH) recognized the Global Harmonization Task Force (GHTF) guidance on Process Validation. They no longer use the 1987 FDA Guidance as it has become outdated, and the Center for Drugs has instituted a separate guidance for other FDA offices.

This webinar will discuss the CDRH interpretation of the GHTF guidance and how manufacturers should develop process validation plans and conduct production process validation. As this webinar focuses on the GHTF guidance, the information here can be used by medical device manufacturers worldwide and not just in the US.

Areas Covered in the Webinar:

• How does the US FDA interpret the GHTF guidance document?
• Why should a company validate production processes?
• What processes require validation?
• How does process validation relate to design validation?
• How does process validation relate to six sigma and SPC methods?
• What type of statistical tools are needed to conduct process validation?
• How do suppliers relate to process validation requirements?
• Where should process validation files be maintained?
• What are the updating requirements for process validation?

Who Will Benefit:

• Manufacturing Engineers
• Process Engineers
• Quality Managers
• Quality Engineers

Instructor Profile:

Edwin Bills, is the Principal Consultant at ELB Consulting in the area of medical device quality, regulatory, product liability and risk management. During his 26 year career in medical devices, Mr. Bills has held a number of quality and regulatory affairs positions. Mr. Bills is ASQ Certified as Quality Engineer, Quality Auditor, and as Manager of Quality/ Organizational Improvement. He also holds a certificate as Regulatory Affairs Certified through the Regulatory Affairs Professionals Society, and a BS and Master’s degree from the University of Cincinnati. Recently, Mr. Bills served as US Industry Co-chair of the Association for Advancement of Medical Instrumentation committee, QM/WG04, on application of risk management to medical devices and is a current member of the international technical committee. He has presented at training courses for the American Association of Medical Instrumentation (AAMI) in the area of risk management and quality systems.

Topic Background:

All medical device companies are required to review its manufacturing processes to determine which processes require process validation, and which processes may be qualified by other methods. The FDA enforces these requirements through its inspection program, and in the last few years well over 1/3 of all inspection observations have occurred in production and process controls. Many of these observations have cited companies for failure to perform adequate process validation.

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