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Monday, June 25 • 11:00am - 12:00pm
#117: Beyond Robotics Process Automation: Next Generation Integrated QMS for R&D

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Component Type: Forum
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-18-529-L04-P; CME 1.00; IACET 1.00; RN 1.00

In this forum, our panel will present an overview of current quality management system (QMS) trends, novel digital approaches to connecting data through the QMS bottom-up process framework, as well as implemented digital use cases. The use case discussions will include a global pharmaceutical company and a global CRO. In detail, the panel will describe the methodology of implementing an integrated, cross-functional, process centric, digital QMS. Further, the panel will conclude the forum by describing and discussing the operational benefits/efficiencies, regulatory obligations and lessons learned in designing and implementing a digital process and customer focused QMS/QRM system.

Learning Objectives

Review and discuss current QMS/QRM systems and practices; Describe next generation technologies to enable data integrations in legacy systems based on process/procedure management; Discuss the benefits of integrating the QMS and QRM together.

Chair

Christina R. Morris

Speaker

Panelist
Ed Chase

Panelist
Brad Haby

Panelist
Kimberly Tableman, MSc


Speakers
EC

Ed Chase

Senior Director, Life Sciences, Pegasystems
BH

Brad Haby

Senior Director of Science, PRA Health Sciences
Brad Haby is currently the Sr. Dir of Data Science at PRA Health Sciences. Brad has built Business Intelligence and Data Science teams from the ground up at PRA. He received his degree in Electrical Eng. from Texas A&M Univ. before becoming a Process Engineer in Semiconductor manufacturing... Read More →
CM

Christina Morris

Senior Manager, Life Science Advisory, Ernst & Young, LLP
Christina has over 17 years of clinical research experience, including over 12 years in pharma in clinical operations, training, quality auditing and quality management systems. She has establish R&D and Consumer Quality Management System to enabled consistent process improvement... Read More →
avatar for Kimberly Tableman

Kimberly Tableman

Head, Digital Clinical Trials, PCPS, GlaxoSmithKline6

Monday June 25, 2018 11:00am - 12:00pm EDT
Room 205C Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  08: R and D Quality-Compliance, Forum