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Monday, June 24 • 11:00am - 12:00pm
#115: Quality Management Post-Quality Management System Implementation In The Wake of ICH E6 (R2)

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-529-L04-P; CME 1.00; IACET 1.00; RN 1.00

The key characteristics of a QMS with a focus on how the size of an organization impacts the QMS characteristics and their risk-based methodologies, including what key learnings organizations of varying sizes can learn from each other’s experiences.

Learning Objectives

Discuss the differing characteristics of a QMS based on the size of the organization; Compare how these characteristics changed in preparation for ICH E6 R2 implementation; Determine whether risk-based approaches vary based on organizational size and what organizations of different sizes can learn from each other.

Chair

Jay A Turpen

Speaker

Assessing Your Clinical Quality Management System: A Comprehensive Review of TransCelerate’s CQMS Assessment Tool
Michael Husovich

Please enter Presentation Title
Lenna Kimball, MBA

Panelist
RJ Doornbos, RPh


Speakers
avatar for Michael Husovich

Michael Husovich

Director, Global R&D Quality, Amgen Inc.
Michael is currently Director of Global R&D Quality Operations at Amgen. Michael is responsible for advancing Amgen's R&D Quality Management System including Business Process Management, Document Management, Issue CAPA Management, Quality Risk Management and driving Operational Excellence... Read More →
LK

Lenna Kimball

Vice President of of Clinical Operations, Lyell Biotech
avatar for Jay Turpen

Jay Turpen

Senior Consultant, The Avoca Group
Jay Turpen is a Senior Consultant with The Avoca Group. He has been in the pharmaceutical industry for 30 years and has held various leadership roles. Jay has a wealth of experience in GMP, GLP, and GCP environments with significant real-life experience in developing numerous new... Read More →
avatar for RJ Doornbos

RJ Doornbos

Head of Global Quality Systems, Global Quality, Bristol-Myers Squibb Company
RJ Doornbos has over 25 years experience in Pharmaceutical Industry in Brand and Generic concentrated in the areas of GxP Quality, Regulatory Affairs and Pharmaceutical Sciences. She has held various roles in Schering-Plough, Merck, Allergan/Teva and more recently in BMS where she... Read More →

Monday June 24, 2019 11:00am - 12:00pm PDT
Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  08: R-D Quality-Compliance, Forum