How to Implement and Maintain a Modern CAPA System While Avoiding the Common Pitfalls
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 devicemakers shape or size.
The numerous challenges related to CAPA implementation make this somewhat unsurprising. Devicemakers often stumble with poor root cause determination, being reactive instead of proactive, poor definition of a CAPA process, overuse versus underuse and more.
Learn how to avoid these common challenges by watching the recording and downloading the slides provided by 20-year medical device industry veteran, Jon Speer, founder and VP of QA/RA at Greenlight Guru.
Speer provides you with best practices to improve your CAPA process and approach so that you can ultimately ensure the medical devices you design, develop, manufacture and sell will be as safe and effective as possible for those patients that depend on them.
Implementing a robust and modern approach to CAPA will allow you to shift from reacting to situations and events to being proactive to address potential areas of concern before they become reality.
Download the presentation to learn:
- How to avoid the most common problems with CAPA
- A best practice, step-by-step guide to implementing a modern CAPA process
- How CAPA connects to your other QMS processes
- The impact of risk management on CAPA
- How you can switch to being more preventative to catch issues before they happen
- With time for Q+A
Who will benefit:
- Medical Device Executives
- CAPA Managers or anyone who participates in your company’s CAPA Board
- Regulatory Affairs Professionals and Management
- Quality Professionals and Management
- Clinical Affairs Professionals and Management
- R&D Engineers and Management
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