February 18, Pre-Dinner Meeting: Leadership in a Regulated Environment (Slides attached)

Be the Change Agent and Ensuring Quality and Compliance

Slides:

ASQ1212 Feb 2015 Leadership in a Regulated Environment – PES ASQ 2-2016 Final (Read-Only)

Our Pre-Dinner Speaker is Peter Shearstone  at 5:30 PM:

Arboretum Club
401 West Half Day Road
Buffalo Grove, IL 60089

Many career opportunities present themselves to regulatory/quality professionals as culture change, remediation or rebuilding efforts within medical device businesses.  The opportunity to solve a warning letter, rebuild a quality system or resolve customer satisfaction issues are among the most frequent in our industry.  Once you’ve successfully started the position you’ll need to help grow the business as the change agent.  How can you fly the plane and change the engine at the same time?   The speaker will offer learnings from his 27 years in the medical device industry on culture change and achieving consistent levels of compliance while growing the business.

Peter has spent 27 years in the medical device industry at a range of different businesses most focus2fc37f8ed on IVD devices. He started as a biotechnology sales person for a small startup in Boston in 1989 and has spent that last two years as the VP for RA/QA/Clinical and Medical Affairs at Sysmex America in Lincolnshire, Illinois. In between those experiences he worked for Ciba Corning, Dade Behring and Abbott Diagnostics along with several other small healthcare businesses in the quality, technical, operations and R&D functions.   He has led global regulatory and quality organizations to change their talent, cultures, costs, processes and systems for the betterment of products, the satisfaction of regulators and the wellness of patients

Peter earned a BS in Biology from Salem State University in Salem, Massachusetts. He represents Sysmex America with AdvaMedDx and MDIC and is a member of RAPS, AACC, CAP and ASQ.

 

Slides:

ASQ1212 Feb 2015 Leadership in a Regulated Environment – PES ASQ 2-2016 Final (Read-Only)