Workshop on managing suppliers in the medical device Industry in Chicago
Atlas Systems is going to organize a workshop on "Managing Suppliers in the Medical Device Industry" on April 7th - 8th 2015.
- Chicago, IL (1888PressRelease) March 05, 2016 - This workshop would help the device manufacturer through a unique format of explanation, discussion, and practical application. The course is built of modules based on the Global Harmonization Task Force (GHTF) guidance document on the control of products and services obtained from suppliers.
During this 2 days of workshop Our speaker Dan O'Leary will speak about the regulatory requirements in the Quality System Regulation (QSR), ISO 13485:2003, the Medical Device Directive (MDD), EN ISO 13485:2012, and other requirements. Participants discuss each phase, using discussion points from the course material and apply multiple points of view: QMS implementers, internal auditors, external auditors, and FDA Investigators.
The workshop would also cover in details:
-Determining when a supplier is a contract manufacturer
-Deciding on a required QMS for a company that makes only components
-When to rely on the supplier's third party QMS certificate
-When to conduct second party audits and establishing their scope
-Preparing suppliers for unannounced visits based on the MDD and EU expectations
-Creating requirements for UDI when the supplier is involved in the device label
-The role of medical device risk management, ISO 14971:2007, for component suppliers
Registration Link: http://bit.ly/1KuskVX
Emailid :puneet.jha at atlassystems dot com
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