Perform Effective Investigations and CAPAs - Webinar Recording/Transcript

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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.

Presentation Takeaways:

  • 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.

  • Quality directors and managers
  • Operations directors and managers
  • Product manufacturing specialists
  • Regulatory auditors
  • Personnel at all levels involved in investigations/CAPA resolution

Susan Schniepp has over 35 years’ experience in Quality Assurance, serving in leadership roles at Searle, Abbott, Hospira, Allergy Laboratories and OsoBio Pharmaceuticals. A winner of the Parenteral Drug Assn. (PDA) Distinguished Service Award and Distinguished Author Award, Ms. Schniepp has served on PDA’s Board of Directors and chaired the PDA/FDA Joint Regulatory Affairs Conference as well as the Regulatory Affairs/Quality Advisory Board. Her book Understanding the United States Pharmacopeia and the National Formulary: Demystifying the Standards-Setting Process won the Distinguished Author Award in 2007 PDA.