Quality Culture: From Buzzword to Implementation and Measurement – Webinar Recording/Transcript
Quality comes into play across all GMP systems — and the FDA needs to see evidence of an effective “quality culture” during facility inspections if you want a passing grade. But what does quality actually mean in a GMP-regulated facility?
In this FDAnews presentation, consultant and regulatory expert Sarah Tanksley demystifies quality culture, helping you implement, measure and sustain a better understanding of quality concepts. You’ll gain the ability to recognize when quality is at risk, as well as sharpen the skills you need to set up actionable strategies for implementation and performance.
- Gain a comprehensive understanding of the working definitions for quality culture
- Learn leading and lagging indicators of quality in a GMP environment
- Grasp the key markers for assessing quality in a GMP facility
- Better understand the FDA’s focus on quality culture and metrics
Gain the skills to build a world-class quality culture in your GMP facility.
Meet Your Presenter
Sarah Tanksley has nearly 25 years of experience in the quality management and regulatory compliance fields. Prior to founding Tanksley Consulting Group, she worked as a principal consultant at PAREXEL Consulting and as a reviewer and investigator with FDA. She is an adjunct professor in GMP and regulatory compliance at Georgetown University School of Medicine’s Masters in Biotechnology Program and Johns Hopkins Advanced Academic Program, and has trained audiences worldwide, including the FDA, on GMP and data integrity topics.
Who Will Benefit
- Drug manufacturers
- Device manufacturers
- API manufacturers
- Contract manufacturers
- Quality professionals
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Oct. 31, 2023