2 Day Seminar Supplier Management for Medical Device Manufacturers

By: Betty Lane, President Be Quality Associates, LLC.
Product code: SEM18
Location 1: Boston Jun 01 - 02


An Interative Workshop Presented BY WCS & Be Quality Associates LLC 
Course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion  

Each attendee will receive 2-Day workshop materials by the speaker. Seminar Also Includes Certificate, 
Complimentary Breakfast, Lunch & High Tea/Coffee provided by WCS 

Supplier selection and management is one of the critical issues for medical device manufacturers. Suppliers provide materials and services to device manufacturers, 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. 
Building partnerships with your suppliers not only helps you meet FDA and ISO 13485 Notifed Body requirements, but can add value to your quality management system and your company.

Since FDA regulations do not allow FDA to audit your suppliers, unless that supplier makes finished medical devices, FDA requires that you have sufficient control over your suppliers. From time to time the FDA makes a reinterpretation of what this means. This is why the Good Manufacturing Practice (aka Quality System Regulations) is called cGMP. The “c” stands for current, meaning what the FDA considers the current state-of-the-art in the areas they regulate. This happened for supplier management within the last few years. So if you supplier management program has not been updated in the last few year, you might need to make major changes to it. In addition European Notified Bodies periodically update their expectations, and for suppliers this happened with the publication of a guidance document by the Notified Body Operations Group (NBOG). 

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 for supplier management.  
One of the major things introduced in these guidance document, is the concept of Risk, and the use of identified risks as part of the evaluation and monitoring of suppliers.  
This seminar will not only review requirements and expectation of the FDA and European Notified Bodies for supplier management, but will guide you on how to incorporate these into your supplier management process.    

Free Handouts for Attendees:  
-  Two guidance documents referenced  
GHTF Guidance document: Quality Management System Medical DevicesGuidance on the Control of Products and Services Obtained from Suppliers  
NBOG Guidance document: Guidance for Notified Bodies auditing suppliers to medical device manufacturers  
-  Example Approved Supplier list  
-  Example Supplier evaluation form  
-  2 examples or Supplier QA Agreements

Areas Covered

- Understand FDA QSR and ISO 13485 requirements for supplier management
- Creating a Risk-based Multi-tier supplier classification system
- Understand when suppliers have to register and list with the FDA
- Defining and using supplier Metrics
- Explain the link between design control and purchasing data
- Develop an risk-based supplier management process
o    Incorporating supplier regulatory and safety risk
o    Incorporating supplier business risk
- Create supplier measurement and monitoring systems
- Understand the how to develop and implement supplier controls
- Create a risk based Value-added system for supplier audits
- How to prepare yourself and your contract manufacturer for unannounced audits from your Notified body
- Creating acceptance criteria and understand how that fits into your supplier control process

Who will Benefit

- Quality Managers  

- Quality Engineers  

- Supplier Managers  

- Supplier Engineers  

- Internal quality auditors  

- Supplier auditors.

Learning Objectives

How well do you understand the requirements for supplier management?

Could you pass a regulatory audit or inspection without any issues?

This course delivers the tools, templates, and methods to help participants implement an effective and efficient supplier management program.

This two-day hands-on course provides a clear understanding of the underlying principles of supplier management. The course uses exercises to solidify understanding.

Course Outline:

(08:30 AM to 05:00 PM)

- Introductions  

- 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  

- Planning the Supplier Management Program  

o Supplier Classification  

o Supplier QA agreements what are they and why are then.


(08:30 AM to 04:00 PM)

- Planning Supplier Selection  

- Potential Suppliers  

- Supplier Selection  

- Implementing Supplier Controls  

- Monitoring, Measuring, and Evaluation  

o Periodic Monitoring  

o Re-evaluations  

- Supplier Audits – where do they add value  

o Planning your supplier audit schedule  

o How Notified Body unannounced audits affect your contract manufacturer

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

Feedback and Communication  
o Supplier meetings: Partnering with Key suppliers

o Supplier Corrective Actions  

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



Betty LanePresident Be Quality Associates, LLC


Betty Lane has over 30 years’ experience in Medical Device quality assurance and regulatory affairs. She is the founder and President of Be Quality Associates, LLC, a consulting company helping small and medium sized medical device and diagnostic companies implement and improve their quality systems for both FDA and ISO 13485 compliance band business when they became FDA and industry requirements. Her are areas of expertise include training, auditing, supplier management, design controls, software validation and general safety.

Betty’s training experience includes over 25 years of training on all areas ISO 13485 and FDA cGMP, in companies where she worked as manager or director, and for AAMI, ASQ biomedical division, and ASQ sections. She has taught courses in medical quality and regulatory affairs as an Adjunct at Northeastern University, Boston, MA. Betty is active in her local section of the American Society for Quality and is

Seminar One Registration
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01-Jun,2017 Boston

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Hilton Garden Inn Boston Logan Airport ($169 / night)

Address: 100 Boardman St, Boston, MA 02128, United States

Phone: +1 617-567-6789

Call our customer care to get the Hotel details Toll Free 844-267-7299

How to Reach


I have attended various seminars from WCS but this "Live" one was incredible. This seminar was excellent.

Pfizer Quality Manager

I liked WCS training style. WCS speakers gave excellent examples to back up what speaker was explaining. Which helped me grasp a better understanding."

RA/QA Manager Abbott

The presenter was excellent session leader, very knowledgeable and well-spoken. The topic was well chosen and interaction between the participants and the presenter was good.

Chief Compliance Officer

This was an informative seminar. Provided very valuable insight into how the FDA works. Presenters' experience in real life events and interaction with the FDA is priceless.

Quality Assurance Medtronic

“I enjoyed the training, the instructor was engaging and were able to modify the course to make it more applicable for small group.”

Peter Belsito, Director of Quality TSI

Awesome material covered.  Andbero Magleo, IT Admin Passy-Muir

“Very informative with enough details to start putting together action plans. Susan Murphy, Associate Director, Quality investigation (QA) LFB USA

“I learned a lot from the instructor and trainee good.” David QU, senior Analytical Chemist Dalton Pharma Services.


“Well placed, a lot of good information. Good interaction between participants. Held at a good location. More was US based examples given.” Nicola Mootoo, Senior Validation Engineer Shire Pharmaceuticals


“Well delivered seminars, right place, good contents.” Evelyn Chang, Corporate manager Genzyme.

“I though the contents of the presentation and the discussion was very good.”Mary Beird, Regulatory Compliance Manager Charles River laboratories International, Inc.


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