Conference

Wednesday, October 22, 2008
9:00 AM - 5:00 PM (Lunch 12:00 PM - 2:00 PM)

Session 202 - Suppliers Chain: A Quality Perspective

Chair: Sue Jacobs, QMS Consulting GHTF Guidance Document: Bruce Haggar, Med-Q-Systems Panel Discussion: Faculty Regulatory Trends FDA Issues with Suppliers Enforcement Climate Headline News Managing the Supply Chain: Sue Jacobs How to demonstrate control over the product or service you provide Quality Plans – how to apply them Contracts/Agreements Supplier Responsibilities, Manufacturers Responsibilities Virtual Manufacturers, Sub-tiered Suppliers, Finished Device Suppliers, Internal Suppliers Who is accountable when things go wrong Application of Risk Management to Supply Chain: Bruce Haggar Evaluating Suppliers Monitoring Supplier Performance - Metrics, etc. MRB/NCMR Process Application of Risk to Supplier Monitoring Supplier Evaluation: Steven Walfish, Statistical Outsourcing How do you decide which suppliers to audit? What are the alternatives to an on-site audit? What gets documented and how? What works; what doesn't? What is due diligence? How does it differ from a supplier audit? What to look for, how to document the results, who to share the results with This supplier evaluation talk helps to define a system to evaluate suppliers to determine when they lack sufficient compliance to meet your Quality Management System (QMS).  The participants will be introduced to the “TEAM” concept that gives measurable metrics for supplier evaluation.  A contrast between an audit and due diligence will be presented. Elements of Supplier Evaluations How to rank suppliers How do you decide which suppliers to audit? Due Diligence How to Document Activities When the System Breaks

 

About the Instructors

Sue Jacobs, Principal Consultant, QMS Consulting
Sue Jacobs is the Principal Consultant for QMS Consulting, Inc. a quality management consulting firm. Having been in the medical device industry for more than 19 years, she is a recognized expert in performing Quality System assessments for compliance to US FDA regulatory requirements and ISO Standards. She assists manufacturers and suppliers in developing and maintaining compliant quality system programs. Prior to forming QMS Consulting, Inc. Ms. Jacobs was a Quality System Consultant with Medical Device Consultants, Inc. (MDCI) and served as the Manager of Quality Assurance for Siemens Nuclear Medicine Group. Ms. Jacobs was the Chairman of ASQ Biomedical Division 2002-04 and is currently serving as a National Director on the ASQ Board of Directors, 2004-06. She participated at meetings of the FDA/Industry Grassroots Task Force which conceived and implemented a program to pre-announce FDA inspections, annotate FDA Form 483s, and send close-out letters after inspections.

Bruce Haggar, President, Med-Q-Systems
Bruce Haggar is currently President of MedQ Systems, Inc. a professional firm specializing in consulting, interim management and education services for the biomedical technology industry.

Mr. Haggar specializes in Process Validation, Design Control, Risk Management and FDA/Regulatory consulting and auditing. He is widely recognized as one of the nation's experts in process validation and medical device design control.

Mr. Haggar is a Biomedical Engineer with experience in a variety of biomedical technology firms in product development, design, manufacturing, and regulatory/quality assurance. He was a primary developer of the external automatic defibrillator technology in the late 1980's at Cardiac Resuscitator Corporation and First Medical Devices, Inc. He is active in various industry organizations including ASQ Biomedical Division where he was the Chair, AAMI, and RAPS. He also served as an Investigator for the U.S. FDA.

Steven Walfish, President, Statistical Outsourcing
Steven Walfish is the President of Statistical Outsourcing Services, a consulting company that provides statistical analysis and training to variety of industries. Prior to starting Statistical Outsourcing Services, Steve was the Senior Manager Biostatistics, Non-clinical at Human Genome Sciences in Rockville MD. Prior to joining HGS, he was a Senior Associate at PricewaterhouseCoopers specializing in the pharmaceutical industry. He brings over 18 years of industrial expertise in the development and application of statistical methods for solving complex business issues including data collection, analysis and reporting. Mr. Walfish has held positions with Johnson & Johnson and Chiron Diagnostics where he worked with large data sets for monitoring process data.