Actions and Detail Panel
2 Day Seminar Supplier Management for Medical Device Manufacturers
Thu, Jun 1, 2017, 8:30 AM – Fri, Jun 2, 2017, 5:30 PM EDT
2 Day Seminar
Supplier Management for Medical Device Manufacturers
Jun 01–02, 2017 Boston
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
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, & High Tea/Coffee provided by WCS
Free Handouts for Attendees"
- Two guidance documents referenced GHTF Guidance document: Quality Management System Medical Devices Guidance 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
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
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
TRAINING WILL BENEFIT :
- Quality Managers
- Quality Engineers
- Supplier Managers
- Supplier Engineers
- Internal quality auditors
- Supplier auditors
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
Meet Your Instructor:
Betty Lane Founder and President 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 asan Adjunct at Northeastern University, Boston, MA. Betty is active in her local section of the American Society for Quality.
Please call for any Assistance of our customer support on 844-267-7299