How To Create A Risk-based CAPA Process

A risk-based CAPA process is a common goal of medical device manufacturers, but until recently “risk-based” was not clearly defined.

The biggest fundamental change in both ISO 9001:2015 and ISO 13485:2016 is an emphasis on risk-based process management.

The CAPA process is the heart of your quality system and one of the most important processes. Therefore, this presentation gives you a whole new set of tools for managing your CAPA process using risk-based approach.


A risk-based CAPA process is more than prioritization.

This webinar goes beyond simple prioritization of CAPAs and color-coding of CAPAs as high, medium and low risks.

Instead, Rob Packard reviews best practices in risk management (i.e., ISO 14971) and he applies the more rigorous risk management process to the CAPA process.

Join us for this free webinar presentation as our speaker helps you integrate risk management activities with your CAPA process.

Watch the webinar

Specifically, this webinar includes:
      • An outline of the CAPA process and proposed risk management activities
      • Various risk control options that can be integrated with corrective actions
      • How to reconcile conflicts between the definitions for risk in ISO 9001:2015 and ISO 13485:2016
      • And more
Who should attend?
      • 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

Hosted by

Presenter: Rob Packard

Founder / Owner, FDA eCopy & Medical Device Academy

Moderator: Jon Speer

Founder & VP QA/RA, Greenlight Guru


About FDA eCopy
Rob started the new FDA eCopy service to print and ship submissions to the FDA, because it saves his clients hours of time when compared to outsourcing the printing to companies like Staples and OfficeMax. The new high-speed printer and the eCopy checklist saves hours for every submission. If you are located outside the USA, this will save you even more time and money. Go here to learn more! As a new customer you will save $100 on your first FDA eCopy submission.


About Greenlight Guru

Greenlight Guru is the only Medical Device Success Platform (MDSP) for companies to bring new products to market faster while simplifying regulatory compliance and reducing risk. Being the only industry specific, cloud-based software, Greenlight Guru is easier to implement, easier to use and designed to fit all medical device needs to enable innovative, safe and effective, True Quality medical devices. Visit our homepage to learn more.

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