Establish and Maintain an Effective Supplier Qualification Program

Duration: 60 Minutes
FDA considers the supplier as an extension of your operation. You are liable for supplier’s conduct (as it relates to your product). FDA will deal with your company in case of product failure, especially as related to end user or patient safety concerns.
Supplier Qualification
Instructor: David R Dills
Product ID: 500077
FDA has the right to see certain elements of your supplier qualification/purchasing controls related proof, i.e., the documentation. Learn why and how to establish and maintain the requirements, including quality requirements, that must be met by suppliers, contractors, and consultants. Understand why you need to evaluate and select potential suppliers, contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements. Document this evaluation or assessment and define the type and extent of control to be exercised based on the evaluation results. You need to establish and maintain data that clearly describe or reference the specified requirements, including quality requirements. This Webinar will identify the key elements of a robust, sustainable and successful supplier qualification program and why FDA is taking a closer look at purchasing controls and supplier qualification programs. The process is critical for device manufacturers to effectively evaluate and select suppliers and subsequently implement agreements ensuring consistent material quality and/or services provided.

The process defines the elements associated with a supplier's processes that are critical to quality. Although a manufacturer's knowledge of supplier operations may be limited and information about the operations difficult to obtain, the GMP requirement that a manufacturer is responsible for quality remains undiminished. To the maximum extent feasible, selection and qualification of suppliers by audits, performance analysis, surveys, etc., should be part of a quality system. Excluding a supplier whose components are unreliable from supplying components may help prevent problems with the final device and is certainly worthwhile as a cost reduction effort. Your system needs to provide performance metrics and reports that enable manufactures to identify top performing and underachieving suppliers based on an effective supplier scorecard or rating program. The system should capture metrics such as number of defects, quality of investigation, responsiveness to corrective action requests, on-time performance, batch rejections, quality deviations, and many other factors.

Objectives of the Presentation:
  • Discuss and review Supplier Agreements, Quality Agreements and other documentation including Contracts, etc.
  • Learn how to apply risk-based approaches and why and how to "rank" suppliers based on criticality and RPN (Risk Priority Number)
  • What to measure and how to measure supplier performance and assign classifications or levels
  • Prepare and maintain the integrity of your Approved Supplier List
  • Elements and sections that must be included in your SOP, checklists, and other areas you should emphasize, including your criteria for critical vs. non-critical or high-risk
  • Classify suppliers based on the risks to the product, patient and liability exposure
  • Understand what to document and how to prove and demonstrate that you have an effective supplier qualification program
  • Learn what records are essential and required to present to any FDA investigator
  • Update on recent FDA enforcement and trends regarding purchasing controls
Who can Benefit: This webinar will provide a valuable and informative overview and guidance to manufacturers, especially medical device companies that are preparing to establish or have established supplier/vendor management qualification programs and may need a refresher in order to make improvements to existing program. The employees who will benefit include:
  • All levels of management and departmental representatives any anyone who desire a better understanding or a "refresh" overview of the supplier evaluation and qualification process
  • Regulatory Affairs/RA Specialists
  • Purchasing
  • Quality
  • Compliance
  • Engineering
  • Technical Services/Operations
  • Consultants
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Live Session - How it works
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  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
David R. Dills, is an independent Global Regulatory Affairs & Compliance Consultant and has an accomplished record with more than 26 years of experience in regulatory affairs, compliance and quality consultative services for early-stage/established Class I/II/III medical devices, IVD's, and bio/pharmaceutical manufacturers on the global landscape. Previously employed, with increasing responsibilities by device manufacturers and consultancies, including a globally recognized CRO, has worked directly with and for manufacturers engaged in compliance remediation activities involving consent decrees, CIA's, FDA warning letters, and customer generated compliance events, provides Strategic GxP Compliance and Regulatory Consulting, handles all aspects of global regulatory submissions and dossiers, including 510(k), PMA and IDE submissions, serves as a U.S. Agent, works with stakeholders and Center Reviewers regarding submission meetings/negotiations, clinical affairs, and provides regulatory submissions and post-market project leadership/guidance covering different therapeutic and medical specialties based on classification. Background encompasses broad capabilities in regulatory and compliance oversight and governance, regulatory and GxP training, and compliance with MEDDEV/MDD/IVDD Directives. Mr. Dills leads and manages efforts involving multi-country product registrations and licensing in Asia Pacific, EU and The Americas from premarketing to postmarketing, and works with the Regulatory Authorities and strives to provide consistent, practical compliance solutions that work with reduction of regulatory compliance risk.
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