Medical Device Supplier Risk Management Training GuideEnsuring Your Suppliers Are FDA Compliant

Devicemakers: Worried about the FDA crackdown on third-party suppliers? Uncertain how to respond? Seeking guidance?

New — from FDAnews Desktop Training
Medical Device Supplier Risk Management Training Guide
Ensure Your Suppliers Are FDA Compliant

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For the first time, we’ve gathered all of our current medical device supply chain training products together — and packaged them into one concise training tool.

Here’s what you get:

Six 45-minute desktop tutorials led by medical device quality assurance experts. This information-packed desktop training tool brings the learning experience right to you — listen in your office, at home or any location of your choice. And you can do it on your own schedule.

You’ll learn from the leaders at top companies — Nixon Peabody, Boston Scientific, Life-Tech, Arizant Healthcare, Ombu Enterprises and Cerulean — how to overcome supplier risk management issues that are challenging medical device manufacturers across the U.S. and internationally, including:

  • The 8 phases of proper supplier control
  • How to train supplier auditors and perform successful audits
  • New strategies for choosing the best CMO or subcontractor
  • GHTF SG3 guidance: Making sure you measure up
  • Secrets of creating low-risk supplier quality agreements
  • Supplier qualification and FDA compliance: Designing the right strategy for you

This must-have educational tool is one of the best high-impact, low-cost training tools you’ll find anywhere. It’s conveniently organized so you can fit it into your busy schedule. Attend one tutorial at a time or spend an afternoon listening to them all. It’s totally up to you.

With this exclusive package, you’ll receive:

  • 6 complete tutorials
  • More than 200 PowerPoint slides with synched audio
  • 270+ minutes of value-packed content
  • Powerful presentations from leaders in supplier quality management
  • Full texts of key guidances and regulations, right at your fingertips

Best of all, you can pass the CD along to your staff members to listen (and learn) as a group — or to individuals to listen on their own. And keep the CD handy on your bookshelf for on-point training when you add to your staff.

Tutorial 1:
Managing Internal and External Suppliers
Seth A. Mailhot, Counsel, Nixon Peabody LLP, Leader of Nixon Peabody's FDA Regulatory Practice Team

Many firms manage their sister facilities the same way they do their own, without distinguishing or addressing the differences in each. But internal suppliers or sister facilities should be controlled in the same way medical device firms inspect and evaluate external suppliers.

Mr. Mailhot addresses the eight phases of proper supplier control: planning, supplier selection, assessment, controls, delivery, measurement, monitoring and feedback (including CAPA). You will:

  • Learn how to use internal audits to decide if sister facilities should be treated as external suppliers
  • Create established procedures with sister facilities that reflect quality requirements based on risk assessments
  • Discuss design control requirements that advise firms what risk analysis they should include as a starting place

Tutorial 2:
Supplier Quality Management Alignment to the GHTF SG3 Guidance: The Boston Scientific Approach
Jim Shore, Principal Design Assurance Engineer, Boston Scientific

The Global Harmonization Task Force Study Group 3 (GHTF SG3) released its final guidance for managing medical device suppliers in December 2008. Over the last year, many firms have been producing gap analysis to see if they measure up to the high standards of these guidance recommendations.

This presentation examines key elements of the guidance and demonstrates how to achieve compliance by following best practices in risk management and quality systems. You will:

  • Understand the nuances of the GHTF SG3 guidance document
  • Learn how to perform gap analysis comparing your current QMS to the guidance document
  • Discover best practices that create a smooth pipeline from implementation to product development and through commercialization

Tutorial 3:
Developing Supplier Quality Auditor Training Programs — Tips and Tricks Revealed
Jeff Kasoff, Director of Regulatory Affairs, Life-Tech, Inc.

To have an effective supplier audit program, your company must have an effective audit team. Supplier audits are often performed either to begin a fruitful relationship or to save a teetering one. It is important that the audit team be trained to get as accurate a picture as possible of the supplier’s quality system, but      also trained in the subtleties of appropriate supplier interaction. Failure in either area could have regrettable implications for your company.

This presentation details effective methods for training auditors and includes tips and tricks for performing supplier audits. You will:

  • Discover successful methods for auditor selection and training
  • Train auditors how to perform supplier audits that will create beneficial relationships
  • Learn auditing tricks to keep in your back pocket when conducting on-site audits

Tutorial 4:
Risk Assessment Tools for Choosing the Right CMO or Subcontractor
Jacqueline Torfin, Director of Quality, Arizant Healthcare

Choosing the right CMO or subcontractor to partner with will set the stage for your compliance and business relationship. Many partners are chosen based on filling out a questionnaire and a quote.

Learn a new strategy using a quantitative risk assessment tool to help you make the right choice for your company’s business and compliance needs. You will learn:

  • The most important things to look for when choosing a partner
  • The most common things that are overlooked in the supplier selection process
  • An easy-to-use ranking tool that helps you hone in on suppliers that will deliver the goods and remain in compliance

Tutorial 5:
Creating Comprehensive Supplier Quality Agreements That Reduce Risk and Improve Contract Deliverables
Dan O’Leary, President, Ombu Enterprises

A quality agreement is a written contract between client and supplier that is intended to prevent critical details from “falling through the cracks.” While these contracts are required by regulations and guidance, there are not clear expectations. The lack of clarity does not stop the FDA from issuing Form 483s regarding these agreements.

This presentation illustrates the content and format of quality agreements and emphasizes important but often overlooked details. You will:

  • Learn how to use a process flow diagram to identify critical control points and tasks that need to be addressed in the quality agreement
  • Discover how to avoid potential quality problems by identifying and addressing them in advance
  • Specify operational expectations within the limits of each party’s capabilities — making sure each party can do what is expected, needed and wanted

Tutorial 6:
Creating a Risk-Based Supplier Qualification and Monitoring Process
John Avellanet, Managing Director & Principal Consultant, Cerulean Associates

Supplier management and oversight is all about balancing risk, regulation, and resources. And it only gets more complicated the more your supply chain stretches around the world. 

In this tutorial, you will learn how to design a risk-based, cost-conscious strategy for supplier qualification and FDA compliance, effectively share the risk and the steps needed to ensure vendor accountability, including how to:

  • Classify suppliers based on the risks to the product, patient and liability
  • Discover what to document to show an effective supplier qualification program
  • Learn what records are essential to present to any FDA investigator

Regulatory Guidance Library

You’ll also receive full-text copies of:

  • FDA Good Importer Practices
  • GHTF SG3 Control of Products and Services Obtained From Suppliers
  • GHTF SG3 Implementation of Risk Management Principles
  • 21 CFR 820.50 Purchasing Controls
  • FDA Medical Device Postmarketing Requirements — Purchasing and Acceptance Activities