How to create a risk-based CAPA process

This webinar explains how to create a risk-based CAPA process, and you will learn how to implement corrective and preventive actions step-by-step.

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Risk based CAPA Process Diagram How to create a risk based CAPA process

When is the webinar on how to create a risk-based CAPA process?

The risk-based CAPA webinar was last recorded on April 5, 2017. We are recording an updated webinar on June 30, 2020, at 8:30 am EDT.  We also recorded a webinar on How to improve your CAPA process on May 17, 2015. The content of both webinars will be combined into the new update webinar. If you already purchased either webinar, you will receive an automated email inviting you to participate in the new live webinar. If this is a new purchase of the webinar, you will receive a link for downloading the old webinars and an invitation to participate in the new live webinar. Everyone that purchases the webinar will receive a link to download the recording if you are unable to attend the live webinar.


Capa how to1 How to create a risk based CAPA process
Create a Risk-Based CAPA Process

How to Create a Risk-Based CAPA Process. This webinar includes the most recent updates to ISO 13485:2016, ISO 9001:2015, and ISO 14971:2019.

Price: $129.00

20- Question Exam and Training Certificate available for $49.00:

Exam CAPA How to create a risk based CAPA process

This is a 10 question quiz with multiple choice and fill in the blank questions. The completed quiz is to be submitted by email to Rob Packard as an MS Word document. Rob will provide a corrected exam with explanations for incorrect answers and a training effectiveness certificate for grades of 70% or higher.

Price: $49.00

Description of the webinar on 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 two quality management system standards, ISO 9001 and ISO 13485 were revised and re-issued. The current versions are: ISO 9001:2015 released in October 2015 and ISO 13485:2016  released in February 2016. The biggest fundamental change in both standards 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 a 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 14971:2019 and ISO/TR 24971:2020) and he applies the more rigorous risk management process to the CAPA process.

This is a “must-see” presentation for anyone that is responsible for the CAPA process or participates in their company’s CAPA Board. Join us for this webinar presentation as our speaker helps you integrate risk management activities with your CAPA process.

This webinar includes:

  • Revised requirements for ISO 9001:2015 and ISO 13485:2016
  • 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
  • Root Cause Analysis Tools
  • 5 Why Analysis
  • Is/Is Not Analysis
  • Fishbone diagrams
  • Brainstorming
  • Pareto analysis
  • Effectiveness checks
  • Sources of corrective and preventive actions
  • Pareto analysis of service issues
  • Trending CAPAs, average aging of CAPAs, “Death by CAPA”
  • Risk Management: risk-based CAPAs, risk thresholds, 7 criteria for estimating risk
  • Documenting CAPAs
  • How to write an effective CAPA SOP
  • Auditing the CAPA process
  • Problem-solving A3 reports
  • Key elements of CAPA forms


SOPS How to create a risk based CAPA process

About Your Instructor

Rob Packard 150x150 How to create a risk based CAPA processRob Packard is a regulatory consultant with 30 years of experience in the medical device, pharmaceutical and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Robert was a senior manager at several medical device companies—including President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certification. From 2009-2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Robert’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications, and 510(k) submissions. The most favorite part of his job is training others. Specialties: CE Marking, Canadian Medical Device Applications, Post-Marketing Activities, Supplier Quality, CAPA, Risk Management, Auditing, Sterilization Validation, Lean Manufacturing, Silicone Chemistry, Extrusion, Bioprocess Engineering, and Strategy. He can be reached via phone 802.258.1881 or email. You can also follow him on Google+, LinkedIn or Twitter.