Data Integrity - The Human Factor: Quality Culture
Recorded
Tuesday, July 4, 2023 · 4:00 p.m.
ABOUT THIS WEBINAR
Data integrity programs often suffer from a severe blindspot: They do not focus on the "soft facts", the human factors!
An intact quality culture is a key enabler together with a strong data governance program to derive Data Integrity and fullfill the ALCOA+ principles. In this webinar we give an overview about regulatory guidance (PIC/S) and best industry practice (PDA, ISPE) and derive ways to implement a strong foundation for your data integrity program.
We will provide real life examples of failing quality culture and how this could impact the reliability of your organization's data.
We will set a view into the near future, to get one step further and enable a living Data Culture.
AGENDA
Introduction: Data Integrity, Data Governance and Quality Culture
The Human Factor: How it impacts Data Integrity
What now? How to support a solid quality culture and data integrity awareness
The future: From Data Integrity and Quality Culture to Data Culture
Dr. Ulrich Koellisch has been on the forefront of the data integrity initiatives and in his previous eight years. He has supported many organizations in the pharmaceutical and biotech sector executing Data Integrity campaigns. Ulrich has...
James Francum is a seasoned Life Science Compliance expert with 20+ years as GxP-CC CEO. Specializing in FDA, EMA & ANVISA, he's worked in 27+ countries with global Life Sciences Industry players. An MBA holder, he's an active member of related...