ASQ - Customer-Supplier Division

Supplier Risk Management

Abstract: A disruption in the supply chain impacts both the customer and supplier. Supplier controls should be implemented to ensure that the risk to the supplier chain is minimized. This talk will present the six phases of supplier controls (Planning, Selection of Suppliers, Supplier Evaluation and Acceptance, Finalization of Controls and Responsibilities, Delivery, Measurement and Monitoring, Feedback and Communication, including CAPA). A case study on failure in the Heparin supply chain will be presented. The talk will focus on methods to evaluate the effectiveness of the supply chain. Participants will have an approach for qualifying, selecting and monitoring suppliers in their supply chain. Presenter: Steven Walfish Mr. Walfish is Principal Science & Standards Liaison in the Global Science and Standards Division at United States Pharmacopeia (USP). Prior to this role Mr. Walfish was Principal Statistician at BD in Franklin Lakes, NJ. He is responsible for supporting continuous improvement efforts and process development for worldwide operations. Prior to BD he was a statistician at GE Healthcare in Waukesha, WI. Previously, Steven was President of Statistical Outsourcing Services, a consulting company that provides statistical analysis and training to the FDA regulated industries. Prior to starting Statistical Outsourcing Services, Mr. Walfish was the Senior Manager Biostatistics, Non-clinical at Human Genome Sciences in Rockville MD. Mr. Walfish brings over 25 years of industrial expertise in the development and application of statistical methods for solving complex business issues including data collection, analysis and reporting. Steven has experience applying statistical methods to design control verification and validation. Steven has been part of three 510(k) submission and numerous meetings with the FDA. Mr. Walfish has been an invited lecturer at Medical Design and Manufacturer (MD&M), Institute of Validation Technology (IVT) and Advanstar conferences. Mr. Walfish has been a speaker at ASQ Division and Section conferences. He is also an editorial board member for BioPharm International, and a regular contributor to the magazine. Mr. Walfish is a senior member of ASQ, a certified quality engineer and past chair of the Biomedical Division (2006-07). Mr. Walfish holds a Bachelors of Arts in Statistics from the University of Buffalo, Masters of Science in Statistics from Rutgers University and an Executive MBA from Boston University.

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