Free on-demand webinar

The Complete Guide to Root Cause Analysis & CAPA

Expert Advice for Establishing Robust Quality System Procedures

45-minute presentation with 15-minute Q&A

For years, failure to thoroughly investigate and correct problems have consistently ranked among the most commonly cited deficiencies and observations for drug and device manufacturers.

Join us for this free webinar, where we revisit the important basics as well as advanced concepts in root cause analysis and Corrective and Preventive Action (CAPA) to help you identify issues and make improvements to your organization's processes.

What we cover:

  • Root cause analysis & CAPA basics
  • Strategies for overcoming common challenges such as defining your CAPA process or determining when CAPA is appropriate
  • CAPA's connection to other parts of your QMS
  • Practical perspectives on shifting to a prevention mindset
  • Firsthand experiences from a former FDA official
  • How third-party specialists can play a vital role in remediation projects

About the Presenter

The FDA Group's Larry Stevens, RAC

Presenter Larry Stevens, RAC, has held almost every field position within FDA during his 21-year career with the Agency. He has over 18 years of experience in the medical device industry, rising from an RA Manager to Vice President of RA/QA/Clinical for major class III device manufacturers.
 
He specializes in planning, creating, and auditing quality systems as well as creating clinical plans, including protocol development, case report form development, and implementing and managing clinical trials. He also assists in design control to meet FDA requirements. Larry is a professional speaker who regularly trains on all aspects of FDA requirements while offering practical, successful solutions to FDA problems.
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