Supplier Management for Medical Device Manufacturers 2 Day Seminar

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San Francisco, CA
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An Interactive 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
Building partnerships with your suppliers not only helps you meet FDA and ISO 13485 Notified Body requirements, but can add value to your quality management system and your company.
Since 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.
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
• Explain the link between design control and purchasing data
• Develop a risk-based supplier management process
• Incorporating supplier regulatory and safety risk
• Incorporating supplier business risk
• Defining and using supplier Metrics for measuring and monitoring of suppliers
• Supplier audits, what is required and what is good practice
• How to prepare yourself and your contract manufacturer for unannounced manufacturing audit
Who will Benefit
Quality Managers
Quality Engineers
Supplier Managers
Supplier Engineers
Internal quality auditors
Supplier auditors.
Learning Objectives
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.t

Course Outline:
Day ONE (08:30 AM to 05:00 PM)
• Introductions
• Fundamentals Regulatory Requirements
• FDA Requirements
• ISO 13485 requirements
• Understanding the role of the Global Harmonization Task Force Guideline
• Understanding NBOC Guideline and why it should be used
• Planning the Supplier Management Program
• Supplier Classification
• Supplier QA agreements what are they and why are then.

DAY TWO (08:30 AM to 04:00 PM)

• Planning Supplier Selection
• Potential Suppliers
• Supplier Selection
• Implementing Supplier Controls
• Monitoring, Measuring, and Evaluation
• Periodic Monitoring
• Re-evaluations
• Supplier Audits – where do they add value
• Planning your supplier audit schedule
• How Notified Body unannounced audits affect your contract manufacturer
• What you should do to prepare yourself and your contract manufacturer for unannounced Notified body audits
• Feedback and Communication
• Supplier meetings: Partnering with Key suppliers
• Supplier Corrective Actions
• Evaluating your current program to see how it measures up to regulatory Expectations

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. Her work enables companies to manage their business in compliance with FDA and ISO 13485 requirements, while having a cost-effective Quality Management System. Her background in digital systems engineering enables her to facilitate implementation of design controls and software validation. Her areas of expertise include training, auditing, supplier management, document and records management, design controls, and software validation. Betty’s training experience includes over 25 years of training on all aspects of FDA Quality System Regulation (cGMP) and ISO 13485, the ISO standard for Medical Device – Quality Management Systems for ASQ, AAMI, and colleges.

Seminar One Registration
$ 795
28-Jul, 2016 San Francisco, CA

Special Group Discount Register for Four attendees
$ 2995
Please call any of our customer support on 844-267-7299 to avail the below discount for your Group
2 Attendees – 2% off
3 to 6 Attendees – 5% off
7 to 10 Attendees – 10% off
10+ Attendees – 15% 0ff

San Francisco, CA

Contact Us
WCS Consulting Inc.
3190 Stirling Rd, Unit K4
Hollywood, FL 33021
Phone: 347 282-5400

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