DESCRIPTION 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

Date : 13th November 2017 to 14th November 2017

Place : Switzerland, Hohenb�hlstrasse

Website :https://www.eventbrite.com/e/supplier-management-for-medical-device-manufacturers-ntz-tickets-36312587928?aff=NDT

Contact Person:Paula Edwards

Description:

DESCRIPTION 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

DESCRIPTION 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 will be held in Hohenb�hlstrasse,Switzerland on date 2017-11-14

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Deadline for abstracts/proposals : 10th November 2017

Keynote Speakers : Betty Lane Founder and President, Be Quality Associates, LLC Betty Lane has over 30 years' experience in Medical Device quality assurance and regulatory affairs. She is the founder and President of Be Quality Associates, LLC, a consulting company helping small and medium sized medical device and diagnostic companies implement and improve their quality systems. Her work enables companies to manage their business in compliance with FDA and ISO 13485 requirements, as well for quality syst

Conference Highlights :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 Regul

Venue :Hohenbühlstrasse 10, 8152 Opfikon, Switzerland

Check the event website for more details.