From Concept to Medicine - A Comprehensive Drug Development Journey

36 – Audit Findings and Corrective and Preventive Actions (CAPA) (S18E4)


Listen Later

This episode examines the critical steps that follow a GMP audit: analyzing findings and implementing corrective and preventive actions (CAPA). We explore how audit findings are categorized and prioritized, focusing on the potential impact on product quality and regulatory compliance. Learn about the importance of root cause analysis, delving deep to understand the underlying reasons behind identified issues.

We'll discuss the process of developing and implementing effective corrective actions to address immediate problems. Explore the role of preventive actions in mitigating future risks and fostering continuous improvement. Learn how a robust CAPA system, including ongoing monitoring and documentation, ensures sustained compliance with cGMP standards and drives a culture of quality within the organization.

...more
View all episodesView all episodes
Download on the App Store

From Concept to Medicine - A Comprehensive Drug Development JourneyBy Jim Mitchell

  • 5
  • 5
  • 5
  • 5
  • 5

5

4 ratings


More shows like From Concept to Medicine - A Comprehensive Drug Development Journey

View all
The Daily by The New York Times

The Daily

110,865 Listeners

The Peter Attia Drive by Peter Attia, MD

The Peter Attia Drive

8,010 Listeners

BioCentury This Week by BioCentury

BioCentury This Week

30 Listeners

The BioCentury Show by BioCentury

The BioCentury Show

11 Listeners