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The Guide to CAPA & Root Cause Analysis in FDA-Regulated Industries

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

In this free guide, 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 you'll find inside:

  • 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

Meet the contributors

Larry Stevens, RAC

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.

Brian Dense

Brian Dense brings over 25-years of industry experience, with more than 20-years working directly in quality systems and assessing compliance with FDA 21 CFR Part 820, Parts 210 & 211, Part 58, ISO 13485 and ISO 9000. Brian is skilled in implementing, managing and maintaining complete quality systems to meet FDA regulations and ISO 9000 and ISO 13485 standards as well as regional and international supplier auditing, supplier controls, nonconforming product, complaint handling and investigation and corrective and preventive action (CAPA.)

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