The "Supplier
Management for Medical Device Manufacturers" conference has
been added to ResearchAndMarkets.com's offering.
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 on supplier management.
One
of the major things introduced in these guidance documents, is the
concept of risk, and the use of identified risks as part of the
evaluation and monitoring of suppliers.
This seminar will
review requirements and expectation of the FDA and European Notified
Bodies for supplier management, and then how to incorporate these into
your own supplier management process.
Since FDA regulations do not allow them to audit your suppliers unless they make finished medical devices, they require that you have sufficient control over them. But from time to time the FDA makes a reinterpretation of what this means. This happened within the last 5 years, so if your supplier management program is older than that, you need to make major changes in your supplier management program.
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. Also European Notified Bodies also periodically update their expectations, and for suppliers this happened with the publication of a guidance document by the Notified Body Operations Group (NBOG).
Key Topics 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
- Incorporating supplier regulatory and safety risk
- 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
For more information about this conference visit https://www.researchandmarkets.com/research/cqmlvn/2_day_course?w=4
View source version on businesswire.com: http://www.businesswire.com/news/home/20180112005232/en/