The Inextricable Link Between Data Integrity and Quality Culture – Webinar Recording/Transcript
Quality culture, quality by design, data integrity — these are more than mere buzzwords. They are the backbone of good manufacturing practice (GMP) and they are inextricably linked, especially in the eyes of the FDA and other regulators. But everyone seems to have a different idea of what these terms mean and how they fit together.
Can you have a culture of quality without strong data integrity protections? Probably not. Does data integrity make a quality culture by itself? No. Is everyone in your organization responsible for setting and maintaining a culture of quality? Absolutely.
In this presentation, industry thought leader Kara Quinn dives deep into the concept of quality culture and the role data integrity plays in it. She explores how different stakeholders in an organization contribute to the culture. She explains how quality culture needs to start at the top with executive leadership promoting and committing to the concept and then filter all the way through a company so that everyone understands what it means, how important it is and how they can contribute to it.
- How the FDA measures quality culture through the lens of warning letters citing data integrity failures
- FDA inspection trends related to quality and data integrity
- How to comply with the FDA’s guidance on data integrity by taking a back-to-basics approach
- How to differentially apply FDA’s guidance to electronic vs. paper-based systems
- How to develop a world-class quality culture incorporating realistic performance outcomes and transparency
- How to develop and implement best practices in right-first-time data capture and continuous data integrity verification, such as quality-by-design and quality risk management
- How to overcome the practical challenges to data integrity and quality culture integration, including human nature and leadership behaviors
Quality culture and data integrity shouldn’t be just lofty goals; they need to be a matter of everyday practice.
Meet Your Presenter
Kara Stockett Quinn's most recent position was as a senior consultant with ValSource Consulting. Prior to consulting, Ms. Quinn was employed with Merck & Co., Inc. for 28 years providing process technical and quality systems support across the small and large molecule product portfolios. Ms. Quinn has a broad range of end-to-end pharmaceutical experience having held positions supporting non-clinical and clinical investigations, clinical development, process scale-up and technology transfer, facility and process validation, commercialization and licensing, PAIs, and quality management systems support for market supply. In recent years Ms. Quinn honed her skills as a subject matter expert in the fit-for-function qualification of bio/pharmaceutical raw materials and novel excipients. She led a team of industry peers in the development and publication of a practical tool for raw material risk assessments.
Who Will Benefit
- Quality assurance professionals (all levels)
- Quality control professionals (all levels)
- Operations personnel (all levels)
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Feb. 9, 2023