Process Validation for Medical Device Manufacturers - ComplianceOnline (Process Validation)

Venue: Online

Location: Palo Alto, California, United States

Event Date/Time: Apr 22, 2011 End Date/Time: Apr 22, 2011
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Description

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 They no longer use the 1987 FDA Guidance as it has become outdated, and the Center for Drugs has instituted a separate guidance for other FDA offices.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 presentation will discuss the CDRH interpretation of the GHTF guidance and how manufacturers should develop Process Validation Plans and conduct production Process Validation.


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Venue

Online
2600 E. Bayshore Road
Palo Alto
California
United States
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Additional Information

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 They no longer use the 1987 FDA Guidance as it has become outdated, and the Center for Drugs has instituted a separate guidance for other FDA offices.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 presentation will discuss the CDRH interpretation of the GHTF guidance and how manufacturers should develop Process Validation Plans and conduct production Process Validation.