Daniel O Leary presents two-day hands-on workshop on tips to implement an effective compliant supplier management program.

1. Supplier Management for
Medical Device Manufacturers
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com

2. Instructor Profile:
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Dan is the President of Ombu Enterprises, LLC, a
company offering training and execution in
Operational Excellence, focused on analytic skills
and a systems approach to operations
management. Dan has more than 30 years
experience in quality, operations, and program
management in regulated industries including
aviation, defense, medical devices, and clinical
labs. He has a Masters Degree in Mathematics, is
an ASQ certified Biomedical Auditor, Quality
Auditor, Quality Engineer, Reliability Engineer, and
Six Sigma Black Belt, and is certified by APICS in
Resource Management.

3. Description:
Supplier selection and management is one of the critical issues for
medical device manufacturers. Suppliers provide components to the
device manufacturer, which means that the suppliers may be critical to
both device performance and on-time delivery. Neither the FDA nor
your notified body regulates your suppliers (with a few exceptions).
They expect you, the device manufacturer, to implement an effective
process for supplier management and performance.
The workshop covers the regulatory requirements from FDA's QSR, ISO
13485:2003, ISO 13485:2016, and the EU variants.This two-day hands-
on workshop delivers the tools, templates, and methods to help
implement an effective, efficient, and compliant supplier management
program.The workshop provides a clear explanation of the underlying
principles of supplier management and uses exercises to help solidify
understanding. The workshop uses FDA Warning Letters to illustrate the
points and provide an opportunity to avoid similar implementation
problems. As part of the practical implementation theme, the course
includes receiving acceptance activities, outsourced processes,
supplier's process validation, supplier auditing techniques, and supplier
issues in management review.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com

4. Objectives of the Presentation:
Understand FDA QSR, ISO 13485:2003, and ISO 13485:2016
requirements for supplier management
Understand the FDA's multitier supplier classification system
Understand when suppliers have to register and list with the
FDA
Use an analysis matrix and radar chart to compare suppliers
Explain the link between design control and purchasing data
Develop an overall supplier management plan
Understand how to develop and implement supplier controls
Create receiving inspection criteria and use them as part of
supplier controls
Develop supplier measurement and monitoring systems
Understand the three application of risk management:
business risk, regulatory risk, and medical device risk
Learn how to determine when to audit a supplier and the
audit's scope
Developing a supplier audit using the backward trace process
approach.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com

5. Who can Benefit:
Quality Managers
Supply Chain Managers
Quality Engineers
Supplier Quality Engineers
Purchasing Professionals
Regulatory Specialists
Production and Process Engineers
Design and Development Engineers
Verification and Validation Specialists
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com

6. Track this Link:
Supplier Management for
Medical Device Manufacturers
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com