Root Cause Analysis and CAPA Controls to address Medical Device Defects

Event Information
Product Format
Prerecorded Event
Conference Date
Tue, Mar 20, 2018
60 minutes
Product Description

Use Manufacturing Process Data to Avoid an Endless Defect-Correction Cycle

When a problem with a medical device arises, the appropriate response is to dig deep to find and fix the root cause. After all, the goal is to prevent the error from repeating. Not only that—you must abide by the U.S. Food and Drug Administration’s quality management system requirements to collect both pre- and post- manufacturing data from customers, quality review panels, R&D, ISO standards, and more.

That’s a tall compliance task—one that many don’t get right: For the past 15 years, the number one reason for FDA 483 Observations and Warning Letters is failure to implement a Corrective and Preventive Actions (CAPA) process.

Don’t be an FDA statistic. Learn how to avoid getting stuck addressing the same quality issues over and over again—or retraining employees multiple times on the same improvements. Join expert speaker Ajit Basrur for an in-depth guide to using root cause analysis and CAPA controls to address medical device defects. Understand how to identify weaknesses in your system, develop a data-driven approach to problem-solving, take remedial actions to strengthen your processes, and put permanent solutions in place.

Getting root cause analysis right is imperative. Otherwise, all your efforts to correct errors and prevent new defects from arising will be futile. After attending this audio event, you will understand how to implement CAPA correctly by taking three key actions: Address problems as they arise, make appropriate system changes based on sound root cause analysis, and proactively evaluate quality data to stop issues from arising in the first place. You’ll be better equipped to follow the FDA’s CAPA guidelines to build a compliant, robust quality control system to the benefit of employees, customers, and stakeholders.

Session Highlights

Here is a taste of what you will uncover:

  • Learn the background and key definitions of CAPA and related FDA regulations.
  • Gain a clearer understanding of FDA, ICH, and ISO requirements, so you don’t get into hot water with the feds.
  • Discover Quality System Inspection Techniques (QSIT), Nonconformity, and CAPA Inputs.
  • Simplify your efforts with Root Cause Analysis tools, such as: 8-Disciplines (8D), the 5 Whys, the Fishbone (Ishikawa) Diagram, and Brainstorming.
  • Learn from examples of Root Cause Analysis and CAPA processes in action.
  • Understand how to take a risk-based approach and stay compliant with FDA regulations.
  • Discover how to avoid being slapped with FDA 483 Observations and Warning Letters

Who Should Attend

  • General Managers
  • QA/QC Managers
  • CAPA Managers
  • Compliance Officers
  • Quality Engineers
  • Operations Managers
  • Management Representatives
  • Internal Auditors
  • Training Managers
  • Any other team members from the quality, operations, customer service, facility maintenance, and metrology departments who contribute to the CAPA activities and investigations.

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

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About Our Speaker

Ajit Basrur


Ajit Basrur is an experienced quality professional in Pharmaceutical and Medical Devices with over 30 years of experience in global compliance. He is a certified Lead Auditor in ISO 9001 and ISO 13485 and ASQ CBA. Ajit has vast experience in quality system elements of 21 CFR Part 820, 21 CFR Parts 210 and 211, ISO 13485, ISO 9001, European Medical Device Directive (93/42/EEC), Japanese MHLW...   More Info
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