Process Validation for Medical Device Manufacturers

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 They no longer use the 1987 FDA Guidance as it has become outdated, and the Center for Drugs has instituted a separate guidance for other FDA offices.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

Areas Covered in the seminar:

• 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?

Who will benefit:

This presentation is designed to provide information for medical device manufacturers not currently acquainted with the requirements for Process Validation for the US market. The program will provide guidance for establishing procedures for validation of production processes.

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

Instructor Profile:
Edwin L. Bills, is the Principal Consultant for Bilanx Consulting LLC, a consulting firm that provides assistance to medical device companies in compliance with US FDA regulations. Edwin has over 20 years experience in the medical device industry and has participated in inspections in seven different FDA. He has been in the primary role for both leading the manufacturing team in an inspection and responding to the FDA inspection reports. In his consulting role he has assisted companies in Warning Letter responses. Edwin has also participated in training FDA personnel in the Quality System Regulation.