DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of the "Supplier Management for Medical Device Manufacturers" conference to their offering.
Supplier selection and management is one of the critical issues for medical device manufacturers. Suppliers provide materials and services to the device manufacturer, 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.
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. In addition, the course uses FDA Warning Letters to illustrate the points and help you learn from others. As part of the practical implementation, the course includes receiving acceptance activities, outsourced processes, process validation at the suppliers' location, supplier auditing techniques, and supplier issues in management review.
The course uses the Global Harmonization Task Force (GHTF) framework, but expands it to cover other issues and techniques important in effective implementation.
Day 1 Schedule
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 2 Schedule
Planning Supplier Selection
Implementing Supplier Controls
Monitoring, Measuring, and Evaluation
- Periodic Monitoring
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
Founder and President
Be Quality Associates, LLC
For more information about this conference visit http://www.researchandmarkets.com/research/78dplq/supplier