Managing Supplier Purchasing Control GHTF Guidance SG3/N17:2008

Managing Supplier Purchasing Control – GHTF Guidance SG3/N17:2008 The FDA regulations for medical devices define the requirements for supplier selection, management, and control. ISO 13485 and ISO 9001 include similar requirements. The Global Harmonization Task Force (GHTF) released a guidance document on controlling products and services from suppliers in six phases.

Supply chains for medical devices are growing in importance as device manufacturers outsource products and services. As some of this outsourcing moves offshore and to low cost countries, the supply chain becomes longer, more diverse, and more difficult to control. The medical device manufacturer, however, has the ultimate responsibility for the product. As a result, manufacturers must have all aspects of the supply chain compliant. The presentation will help you understand the expectations of the GHTF guidance document.

Take-aways:

 Describe the GHTF guidance on supplier management

 GHTF Document aligned with the Quality System Regulation (21 CFR Part 820)

 Explain the six phases in the GHTF approach to manage suppliers

 A Lifecycle approach for managing suppliers

Speaker biography: Bob Mehta Bob is the principal consultant at GMP ISO Expert Services. Bob brings over 20 years of experience working at Allergan and Edwards Lifescience, manufacturers of pharmaceutical, biologics, and medical devices. He has managed cGMP areas of quality, regulatory compliance, supplier quality, R&D, cGMP laboratories, global technical operations, and change control functions. Bob has participated in corporate audit programs to perform GMP, ISO/TUV (9001 and 13485), ICH (Q7A), and pre-approval inspection of global vendors, suppliers, and third party manufacturers. He has provided global training and presentations on risk assessment, ISO 9001, ISO 13485, CAPA, Supplier Management, and Six Sigma methodologies. He teaches quality assurance, process improvement, and risk management courses at North Orange County Community College, University of Redlands, American Society for Quality (ASQ), and the University of California, Riverside.

Bob holds a bachelor's degree in chemistry from Ahmedabad Science College, India, a master's degree in business administration from Pepperdine University, and a second master's degree in quality assurance from California State University, Dominguez Hills. In addition, Bob is ASQ Certified Quality Auditor (CQA), Biomedical Auditor (CBA), Six- Sigma Black Belt (CSSBB), Quality Engineer (CQE), Software Quality Engineer (CSQE), Reliability Engineer (CRE), Pharmaceutical GMP (CPGP) and Lean Pharma certification recipient from Michigan Engineering College.