How to meet and exceed FDA and your ISO 13485 notified body’s expectation. Robust Supplier Risk Management for Medical Device Manufacturers

John E. Lincoln

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Supplier selection and management is one of the critical issues for medical device manufacturers. Suppliers provide materials and services to the device manufacturer, which means that they can be critical to performance and delivery of your device. Neither the FDA nor your notified body regulates your suppliers (with a few exceptions). They expect you to have an effective process to ensure your suppliers perform in the regulatory environment.

This 6-hour webinar provides a clear understanding of the underlying principles of supplier management that are the current expectation of the FDA and European Notified bodies. The Global Harmonization Task Force (GHTF) and NBOG guidelines that are the basis for these expectation are explained. You will learn how to create or update your Supplier Management System to comply with these guidelines and the expectation under ISO 13485:2016. Implementation examples illustrate how these principles can be implemented. 

This seminar will go into the details of the NBOG supplier guidance document and a GHTF (Global Harmonization Task Force) guidance that describes the current FDA expectation on supplier management. 

Course Objective:

This course delivers the tools, and methods to help you implement an effective and efficient supplier management program to make sure it meets the current expectation of the FDA, European Notified Bodies and ISO 13485:2016.

Specific objectives include:

·    Understand FDA Quality System Regulation (cGMP) and ISO 13485 requirements for supplier

·    Understand the role of risk management in your supplier management system.

·    Including Medical Device Directive (MDD) compliance

·    Create a compliant suppler management process

·    Create a Risk-based Multi-tier supplier classification system

·    Create and use supplier measurement and monitoring systems

·    Supplier auditing and communication

Course Outline:

        ·      Fundamentals Regulatory Requirements

                    o   FDA Requirements

                    o   ISO 13485 requirements

                    o   Understanding the role of the Global Harmonization Task Force Guideline

                    o   Understanding NBOC Guideline and why it should  be used 

        ·         Risk Management for your supplier process

        ·         Planning Supplier Selection

        ·         Potential Suppliers

        ·         Supplier Selection

        ·         Implementing Supplier Controls

        ·         Ongoing Supplier Monitoring

        ·         Supplier Re-evaluations

        ·         Supplier Audits – where do they add value

                     o   What you should do to prepare yourself and your contract manufacturer for unannounced Notified body audits

        ·         Feedback and Communication

        ·         Supplier Corrective Actions

        ·         Evaluating your current program to see how it measures up to regulatory Expectations

Target Audience:

        ·         Quality professional with 3-15 years’ experience

        ·         Quality professionals with the responsibility for Supplier Management in their company

        ·         Quality Managers who need to stay current

        ·         Regulatory Compliance professionals 

        ·         Quality auditors who need to keep up to date with what ISO 13485 Auditors are expecting

        ·         Supplier Engineers who qualify or audit supplier

        ·         Internal auditors who need to make sure their company’s supplier management and control program meets the current                                            requirements

       ·          Quality Consultants who need to be up-to-date with current requirements

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Speaker: John E. Lincoln,

John E. Lincoln, is Principal of J. E. Lincoln and Associates, a consulting company with over 29 years experience in U.S. FDA-regulated industries. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D).In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. John is a graduate of UCLA




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(315) 632-0735,
(315) 750-4379

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212-751-3500