Process Validation for Medical Device Manufacturers

This webinar for medical device manufacturers will discuss the CDRH interpretation of the GHTF guidance and how manufacturers should develop process validation plans and conduct production process validation.

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 They no longer use the 1987 FDA Guidance as it has become outdated, and the Center for Drugs has instituted a separate guidance for other FDA offices.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