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Monday, June 20 • 1:30pm - 2:30pm
#114: Data Integrity Across the Product Lifecycle

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-22-515-L04-P ; CME 1.00; RN 1.00

This session will provide an educational lesson on the latest guidance documents (e.g., EMA) and their impact to data integrity and trends observed in regulatory actions. A case study on Data Integrity will be presented and how it impacted product approval through accelerators, and finally lessons on preparing for data integrity for supply chain and manufacturing through master data management

Learning Objectives

Describe the latest regulatory trends and how they translate to data integrity operations; Discuss how to manage and assess data operations with third parties effectively and compliantly; Define critical aspects of compliant data governance management systems; Apply data integrity strategies to the product approval process

Chair

Brooke Casselberry, MS, RAC

Speaker

Data Integrity in GCP: Trends in 2021 and Beyond
Ulrich Koellisch, DrSc, PhD

Data Integrity Across the Preclinical and Development Life Cycle and it’s Impact on Product Development and Commercialization
Patrick Dentinger

Impact of Data Integrity on Supply Chain
Christoph Krahenbuhl



Speakers
avatar for Patrick Dentinger

Patrick Dentinger

Chief Executive Officer, CellPort Software, LLC, United States
Patrick Dentinger is CEO of CellPort Software. Prior to CellPort Mr. Dentinger Co-Founded Absorption Systems, an analytical CRO in 1996, and was CEO until its sale in November 2020 to Pharmaron. At Absorption Systems, a need was identified to do away with paper lab notebooks and digitalize... Read More →
avatar for Ulrich Koellisch

Ulrich Koellisch

Manager Data Integrity Operations, GxP-CC, Germany
Dr. Ulrich Koellisch has been on the forefront of the data integrity initiatives and in his previous six years. He has supported many organizations in the pharmaceutical and biotech sector executing Data Integrity campaigns. Ulrich has experience in consulting for audit preparation... Read More →
avatar for Christoph Krahenbuhl

Christoph Krahenbuhl

Senior Director, Excellis Health, United Kingdom
Christoph Krähenbühl’s background in the pharma industry includes Supply Chain, Master Data, Serialisation / Traceability and Product Security. Working for Swiss and then UK-based global leaders, he then founded 3C Integrity Consulting that became part of Excellis Health Solutions... Read More →


Monday June 20, 2022 1:30pm - 2:30pm CDT
Room 183 B McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  03: Data-Tech in Clinical Trials, Session |   08: RD Quality-Compliance, Session