GlobalCompliancePanel to organize RAPS pre-approved webinar on "Establish and Maintain an Effective Supplier Qualification Program"

Top Quote "Establish and Maintain an Effective Supplier Qualification Program" is the topic of a RAPS pre-approved webinar that GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organizeon December 13.David R. Dills, Regulatory and Compliance Consultant, will be the Speaker at this session. End Quote
  • Fresno, CA (1888PressRelease) December 13, 2012 - When it comes to a medical device manufacturer's 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 manufacturer's operations and holds the manufacturer responsible for many of the supplier's 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 manufacturer's 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:
    o Learn the pre-selection, selection and assessment process through the use of various tools
    o Methods, techniques and strategies that work and are proven with supplier relations and qualification
    o Learn how to apply risk-based approaches and why and how to "rank" suppliers
    o Supplier Agreements, Quality Agreements and other documentation including Audits/Assessments
    o What to measure and how to measure supplier performance and assign classifications or levels
    o Selection and qualification of suppliers by audits and performance analysis are part of your quality system
    o Approved Supplier List and areas to be targeted during the assessment or evaluation
    o Learn the elements of the SOP and the assessment of supplier capabilities

    When:December 13, 10:00 AM PDT | 01:00 PM EDT

    By whom:
    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.

    For whom:
    The webinar will benefit
    o All levels of Management and personnel from all departments who desire to learn how this process works
    o QA/QC/Compliance/Regulatory Affairs
    o Engineering/R&D/Technical Services
    o Purchasing/Procurement/Sourcing
    o Consultants
    o Operations/Manufacturing/Validation

    Duration: 90 minutes

    To enroll for this webinar, contact
    webinars ( @ ) globalcompliancepanel dot com
    Phone: 800-447-9407

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