Device Contract Manufacturer and Supplier Management Agenda

10:00 a.m. – 10:15 a.m.

Introduction to the Virtual Conference Chairperson, Janice Olson, Vice President of Regulatory and Quality Services, EduQuest

10:15 a.m. – 11:00 a.m.

Opening Keynote: Supplier Controls — FDA Medical Device Requirements
The FDA has been actively focusing on the protection and integrity of contract manufacturers and suppliers for medical devices. Understanding the FDA’s approach is essential to ensuring compliance and avoiding compliance problems. In this session Melissa Torres will take you through the latest FDA policies and processes.

Attendees will learn:

  • Common contract manufacturer and supplier issues the FDA uncovers in medical device inspections and how can firms avoid them
  • How suppliers, contractors and consultants should meet the requirements established by the finished device manufacturer
  • After the initial assessment or evaluation, tips for determining the combination of assessment methods, and how to include third party or product certification

11:00 a.m. – 11:45 a.m.

Assuring the Inspectional Preparedness of Your Contract Manufacturers and Suppliers — Tips and Techniques You Can Use Today!
Outsourcing to a supplier doesn’t mean the firm is ready to handle a regulatory inspection.  One weak design transfer from the contracting firm increases your risk of regulatory scrutiny and potentially impacts your supply chain.  And if your contractor or supplier isn’t well prepared for an FDA inspection, the subsequent enforcement follow up is even tougher to manage.  This presentation will walk you through the best practices for assuring the preparedness of your contract manufacturers and suppliers before you sign on the dotted line — and how to manage them going forward.

Attendees will learn:

  • FDA expectations for management of Contract Manufacturers and OEMs
  • Factors to consider in the supplier selection process
  • Tools and techniques for assuring firms are ready to undergo regulatory inspection
Tips for follow up and on-going monitoring of contracted firms

11:45 a.m. – 12:00 p.m.


12:00 p.m. – 12:45 p.m.

You Can’t Abdicate Your Validation Requirements Through Outsourcing — Best Practices for Teaching and Managing Validation Programs With Contract Manufacturers and Suppliers
Outsourcing to a contractor or supplier doesn’t mean your validation obligations are over — even if you’ve worked with and trusted these suppliers for years. Your reputation to your customers and the FDA is still on the line. No matter what your component supplier, welder, plastics vendor, OEM or packager says about its ability to do the job, you need to know your suppliers have an effective and compliant validation strategy in place.  You cannot abdicate your regulatory responsibilities with the stroke of a pen.  Learn from Janis Olson, a former FDA investigator and computer validation expert, how to do it right. Based on her 30 years of front-line work with device makers and suppliers, Jan will walk you through the best practices for auditing and monitoring contract manufacturers and suppliers before you sign on the dotted line — and how to manage them going forward.

Attendees will learn:

  • FDA expectations for validation assurance
  • Tools and techniques for monitoring contractor validation programs
  • Lessons from FDA Warning Letters
  • How to avoid common supplier management mistakes

12:45 p.m. – 1:30 p.m.


1:30 p.m. – 2:15 p.m.

Do’s and Don’ts for Implementing Effective Contract Manufacturing and Supplier Agreements Through Quality Agreements
Quality agreements are becoming more prevalent and expected of companies by the FDA and business partners. It is crucial to prepare an agreement to ensure regulatory compliance and define the roles of all parties involved.

Attendees will learn:

  • Mistakes made in the quality agreement drafting process
  • Recommendations to maximize the benefits of quality agreements
  • What is expected from both parties in a quality agreement

2:15 p.m. – 3:00 p.m.

Assessment Tool for Choosing the Right Subcontractor or Supplier
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.
Attendees will learn:

  • Learn the areas of competency you should be assessing your suppliers on
  • Determine how to implement the assessment tool in more than one way in your organization
  • See the tool in action through an actual case study

3:00 p.m. – 3:15 p.m.

Closing Comments and AdjournmentChairperson, Janice Olson, Vice President of Regulatory and Quality Services, EduQuest