The FDA will be putting a lot more emphasis on purchasing controls and supplier selection and audit requirements for medical device manufacturers. In December of 2008 the Global Harmonization Task Force issued a guidance document on “the Controls of Products and Services Obtained from Suppliers” detailing the requirements and expectations manufacturers must meet to exert more control over their suppliers.

This audio conference presentation reviews those expectations and the details of the new guidance document, and also discusses how these new requirements affect medical device manufacturers. Our speaker also looks at how design and development, risk management and process controls are intricately linked to purchasing controls.

This audio conference covers:

• FDA's new emphasis on supplier controls
• Purchasing controls and the quality systems regulations for medical devices
• The important elements of the new guidance document on purchasing controls
• The link between purchasing controls and design controls, risk management and process validation
• Decision tree for identifying the level of supplier controls

About the speaker:

Dr. Vinny Sastri is the president of WINOVIA® LLC, a company that provides customized solutions, strategies, and implementation of effective product life cycle management and quality management processes. Areas of expertise include product design and development, design controls, process validation, FDA and ISO quality systems for medical devices and pharmaceuticals, manufacturing, risk management, CAPA, and plastics and materials.

He is a certified Six Sigma black belt and is also on the faculty of the Association for the Advancement of Medical Instrumentation (AAMI) that provides training on the FDA Quality Systems Regulation and Industry Practice to the medical device industry. Dr. Sastri’s book “Plastics in Medical Devices: Properties, Requirements and Applications” was released on April 1st, 2010 by Elsevier, London.

Who should attend?

• Purchasing Managers
• Supplier Quality Engineers and Managers
• Quality Managers and Engineers
• Regulatory Managers
• R&D
• Validation Engineers