20 Mar 2018 to 20 Mar 2018
20 Mar 2018
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.
Why should you attend:
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 f 5 years, so if you supplier management program is older than that, you need to make major changes in you 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).
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.
Areas Covered in the Session:
- 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