Establish and Maintain an Effective Supplier Qualification Program

Training Options

  •   Duration: 90 Minutes  
  • Recorded Access recorded version only for one participant; unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
    Price: $295.00
  • Refund Policy

Overview:

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.

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. Identify the key elements of a robust, sustainable and successful supplier qualification program. 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. It also defines how conformance to manufacturer requirements will be monitored and verified.

Areas Covered in the Session
:
  • Learn the pre-selection, selection and assessment process through the use of various tools
  • Methods, techniques and strategies that work and are proven with supplier relations and qualification
  • Learn how to apply risk-based approaches and why and how to "rank" suppliers
  • Supplier Agreements, Quality Agreements and other documentation including Audits/Assessments
  • What to measure and how to measure supplier performance and assign classifications or levels
  • Selection and qualification of suppliers by audits and performance analysis are part of your quality system
  • Approved Supplier List and areas to be targeted during the assessment or evaluation
  • Learn the elements of the SOP and the assessment of supplier capabilities

Who Will 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. The employees who will benefit include:
  • All levels of Management and personnel from all departments who desire to learn how this process works
  • QA/QC/Compliance/Regulatory Affairs
  • Engineering/R&D/Technical Services
  • Purchasing/Procurement/Sourcing
  • Consultants
  • Operations/Manufacturing/Validation
David R. Dills, Regulatory Affairs & Compliance Consultant currently provides regulatory, compliance and quality consultative services for medical device and pharmaceutical/combination manufacturers, and also has an accomplished record with more than 24 years of experience with Class I/II/III medical devices, In Vitro diagnostics, and pharmaceuticals in the areas of Regulatory Affairs, Compliance and Quality Systems. He has been previously employed, with increasing responsibilities by medical device manufacturers and consultancies, including a globally recognized CRO.

Since 2000, has provided consultative services on behalf of manufacturers and subcontracted by third-party consultancies and provides services involving all phases of the product development, submission, and commercialization process; Agency inspection readiness preparation and remediation; preparing Agency responses due to enforcement actions; conducting audits and assessments and preparing CAP/remediation plan; compliance engineering support, regulatory planning; post-marketing surveillance and vigilance reporting; clinical affairs, establish and/or remediate Quality Management and documentation systems for GxP compliance; preparation for ISO 13485 registration and CE Mark; and multi-country product registrations and licensing.

Mr. Dills manages quality, regulatory and compliance projects with multiple competing priorities having a direct impact on site operations/commercial opportunities. Develops strategies for governmental approval to introduce new products to market, provides guidance and counsel on regulatory requirements, prepares and reviews device submissions [e.g., 510(k), PMA, IDE], including design dossiers and technical files, and other applications/registrations for the Pacific Rim, The Americas and EU. Directs and leads efforts in establishing and retooling QA systems with emphasis on preventing the design, manufacture, and shipment of defective products.

Mr. Dills manages regulatory problems (e.g. AE’s, MDRs, Agency enforcement, and complaints) related to development, manufacturing, and commercialization, and recommends action to senior leadership to ensure effective resolution for manufacturers to achieve sustainable and proven compliant systems. Background encompasses broad capabilities in quality systems, regulatory, design controls and new product introduction, CAPA, software and process validation with compliance oversight, supplier management, and interfaces with FDA and other governmental agencies on the regulatory landscape, strategic compliance with MDD/IVDD Directives, ISO 14971/13485, and demonstrates credible experience to optimize business performance through proactive strategies to mitigate compliance exposure.

Mr. Dills also develops strategies and adds business value to manufacturers by providing strategic and tactical solutions that facilitate the achievement of regulatory and quality milestones and on minimizing delays due to noncompliance. He conducts Compliance Governance Assessments and provides assistance during inspections and with post-inspection correspondence and meetings, involved in the product life cycle and commercialization process and works effectively across all functions for overall corporate compliance to support a company’s goals and strategies.

Mr. Dills analyzes the benefits/risks for informed decision-making; interprets the regulatory precedents and new legislation; understands the competitive landscape; develops the business and regulatory approach; conducts persuasive communication with authorities (FDA and international Agencies); executes an effective path to approval; assists with GxP compliance strategies, effectively coordinates development in multiple markets; selects appropriate testing and manufacturing suppliers; and strives for overall corporate compliance with regulations in The Americas, EU, Pacific Rim and other locales.

Mr. Dills provides direction on understanding the regulatory landscape for the product and provides a fully integrated approach to device development including design controls, and effective communications with Regulatory Authorities related to product development and post-marketing activities.

Mr. Dills has served on the Faculty Advisory Board for the Pharmaceutical Training Institute and currently serves on the 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 and on the Readers’ Board for Medical Device & Diagnostic Industry and Medical Product Manufacturing News and was nominated and accepted for inclusion into the 2005-2006 Strathmore’s Who’s Who of Professionals.

Mr. Dills has authored and published validation, regulatory and compliance-related articles, commentaries and technical guides, and is an accomplished global industry presenter. Mr. Dills’ academic degrees include Environmental Science and Biology. He is a former Chair and Co-Chair of ASQ’s Section 1506 and associated with the Biomedical Division, RAPS, AdvaMed, PDA, ISPE, and other industry working groups.


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