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.
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
Who will benefit:
• Quality Managers
• Quality Engineers
• Audit Managers
• Supplier Engineers
• Internal quality auditors
Location: Washington, DC Date: March 23rd & 24th, 2017 and Time: 9:00 AM to 6:00 PM
Venue: Courtyard Arlington Crystal City/Reagan National Airport
Address: 2899 Jefferson Davis Highway Arlington, VA 22202 USA
Use CNY2017 Promo Code to Get Flat 50% OFF on ALL SEMINARS
Expire Date : 01-January-2017
Register now and save $200. (Early Bird)
Price: $1,295.00 (Seminar Fee for One Delegate)
Until February 15, Early Bird Price: $1,295.00 from February 16 to March 21, Regular Price: $1,495.00
Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*
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