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Wednesday, June 27 • 8:00am - 9:15am
#311: Harnessing the Power of Data and Analytics to Enhance Quality

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-630-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will explore multiple ways that quality professionals can take advantage of data generated across their company and turn data into insights to drive quality improvement. Presenters will review how biostatistical analytic tools from risk-based monitoring can be leveraged to improve audit planning and conduct, including a case study to demonstrate the effective use of these tools. The discussion will then turn to leveraging audit data and metrics for risk identification, evaluation, mitigation and effective CAPA. This presentation will draw upon analysis of data from GCP audits conducted globally over three years. Finally, the session will conclude with a presentation on predictive analytics that leveraging a range of information across an R&D organization to yield tangible insights about the risk of quality events in clinical development.

Learning Objectives

Assess the range of data sources, information, and tools that could be leveraged by clinical quality organizations; Discuss different approaches for turning data into insights, from simple metrics to advanced analytics.

Chair

Ann Meeker-O'Connell, MS

Speaker

Augmenting Clinical Research Site Audits with Statistical Analysis Tools
Gloria Miller, RAC

Leveraging Audit Data and Metrics for Risk Identification and Evaluation
Shehnaz Kairas Vakharia, MSc

Industry Perspective
David Donohue, MBA



Speakers
DD

David Donohue

Head, Quality Data Analytics, Systems, Operations, and Optimum, GlaxoSmithKline
David Donohue leads the Quality Data Analytics, Systems and Operations, Global Quality Assurance He is accountable for defining and delivering the data analytics program to proactively identify trends, emerging issues and shared learnings for Pharma R&D, the systems that underpin... Read More →
avatar for Ann Meeker-O'Connell

Ann Meeker-O'Connell

Senior Director/ Head, BioResearch Quality and Compliance, Consumer Products, Johnson & Johnson
Ann Meeker-O’Connell heads BioResearch Quality and Compliance for Johnson & Johnson’s Consumer sector, with global responsibility for GCP, GLP, and PV oversight. Prior to J&J, Ann led the Division of GCP Compliance at FDA’s Center for Drug Evaluation and Research. Ann has more... Read More →
avatar for Ann Meeker-O'Connell

Ann Meeker-O'Connell

Vice President, Global Head, Quality Assurance, IQVIA
Ann Meeker-O’Connell is the Vice President and Global Quality Head at IQVIA. Ann has more than 20 years of experience in pharmaceutical and cosmetic research and development, including heading the Division of GCP Compliance at FDA’s Center for Drug Evaluation and Research. Ann... Read More →
avatar for Gloria Miller

Gloria Miller

Associate Director QARC, ADAMAS Consulting LLC
Gloria Miller started her career with Burroughs Wellcome Pharmaceuticals as a Developmental Scientist. She utilized her laboratory experience in drug development to move into research with clinical research organizations. Gloria has more than 20 years of auditing experience gained... Read More →
avatar for Gloria Miller

Gloria Miller

ADAMAS Consulting LLC
Gloria Miller started her career with Burroughs Wellcome Pharmaceuticals as a Developmental Scientist. She utilized her laboratory experience in drug development to move into research with clinical research organizations. Gloria has more than 20 years of auditing experience gained... Read More →
avatar for Shehnaz Vakharia

Shehnaz Vakharia

Managing Director, ADAMAS Clinical Quality Consulting Pvt Ltd
Shehnaz started her clinical research career with Pfizer India in 1997, as a CRA. She then moved to Data Management followed by Head Quality Standards for the Pfizer India Medical Department. Post Pfizer, Shehnaz worked as an independent audit consultant, until 2013 when she joined... Read More →


Wednesday June 27, 2018 8:00am - 9:15am
Room 205C Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA