Perform Effective Investigations and CAPAs - Webinar Recording/Transcript
Perform Effective Investigations and CAPAs: Key Steps to Avoid Regulatory Citations
The Corrective and Preventive Action (CAPA) process is the heart of any quality management system. And yet, year after year, CAPA violations are the most frequently observed Quality System subsystem cited by FDA regardless of the manufacturers shape or size.
Susan Schniepp — a Distinguished Fellow at Regulatory Compliance Associates with more than 35 years of experience in quality assurance — will discuss the importance of effective CAPA and investigations management and share best practices for creating effective programs.
- Establish meaningful effectiveness checks
- Conduct world-class investigation process overviews to drive continuous improvements and help comply with regulatory requirements
- Use discovery through closeout for every deviation from CAPA guidelines
- Develop the skills and tools of an effective investigator, including the ability to conduct root cause analysis and to identify root causes
- Take CAPAs through first understanding regulatory definitions and interpretations
- nderstand the nuances involved in lab OOS investigations
Everyone involved in investigations and CAPA resolution in your organization will benefit.