subject: Raps Pre-approved Webinar On establish And Maintain An Effective Supplier Qualification Program [print this page] Description: Description:
When it comes to a medical device manufacturers Supplier Qualification Program, the FDA seems to go by the philosophy of the proverb, Judge a man by his friends. It considers the supplier as a logical extension of a medical device manufacturers operations and holds the manufacturer responsible for many of the suppliers actions, as they relate to the device, especially in case of a failure.
The FDA reserves the right to ask for and inspect documents relating to a medical device manufacturers supplier qualification/purchasing controls. This webinar will offer expertise on how and why to choose a particular supplier, contractor or consultant; what quality requirements to expect from them; how to evaluate them for meeting specific requirements and how, and many other related questions.
This webinar will familiarize participants with ways of documenting this assessment and define the extent and kind of control that the manufacturer will exercise over the supplier, contractor or consultant. It will help them identify the key elements of a robust, sustainable and successful Supplier Qualification Program, which is extremely important if device manufacturers have to effectively evaluate and select suppliers and subsequently implement agreements to ensure consistent material quality and/or services provided. This program will also define how conformance to manufacturer requirements has to be monitored and verified.
This session will cover the following areas:
oLearn the pre-selection, selection and assessment process through the use of various tools
oMethods, techniques and strategies that work and are proven with supplier relations and qualification
oLearn how to apply risk-based approaches and why and how to "rank" suppliers
oSupplier Agreements, Quality Agreements and other documentation including Audits/Assessments
oWhat to measure and how to measure supplier performance and assign classifications or levels
oSelection and qualification of suppliers by audits and performance analysis are part of your quality system
oApproved Supplier List and areas to be targeted during the assessment or evaluation
oLearn the elements of the SOP and the assessment of supplier capabilities
David R. Dills, Independent Regulatory & Compliance Consultant, worked for PAREXEL Consulting till July 2008, when he had to leave due to a service line organizational shakeup. Prior to joining the consultancy, Mr. Dills provided independent consultative services in various capacities from pre-marketing to post-marketing within the technical, quality, regulatory affairs and compliance arena to pharmaceutical, Class I/II/III medical devices, in-vitro diagnostics and biologics/biotech companies with an emphasis on establishing sustainable compliance systems.
David currently serves on the Faculty Advisory Board for the Pharmaceutical Training Institute and Editorial Advisory Boards for Software Quality Professional and the Institute of Validation Technology (IVT), publisher of the Journal of GXP Compliance and Journal of Validation Technology. He also serves on the Readers' Board for Medical Device & Diagnostic Industry and Medical Product Manufacturing News and as Advisor for the ASQ's Section 1506. He is a former Chair and Co-Chair and an active member of the Biomedical Division, RAPS, PDA, ISPE, and other industry working groups.
David has authored and published validation, regulatory and compliance-related articles, commentaries and technical guides, and is an accomplished global industry presenter.
