Seminar on Managing Suppliers in the Medical Device Industry in Boston
Boston, MA, September 2, 2015 (Newswire.com) - Event Date: October 22nd – 23rd 2015Speaker : Dan O’Leary Duration: 2 days
This seminar 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.
Speaker Dan O'Leary has more than 30 year's experience in quality, operations, and program management in regulated industries including aviation, defence, medical devices, and clinical labs.
Dan O'Leary, Speaker
During this 2 days of seminar 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.
The course includes major topics that currently create problems. Among these are:
- 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/1Mm9vDf
Emailid : puneet.jha@atlassystems.com
