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CAPA and Root Cause Investigation Training for Medical Devices

Every RA/QA manager has struggled with repeat CAPAs. A problem you thought had been solved pops up again months later, but why? Persistent problems are not only annoying, they can also endanger patient safety, cost money, and steer internal focus away from other issues.
 
We’ve helped many companies assess the health of their CAPA systems and find that it often comes down to the basics: determining the need for CAPA and defining the problem. This course provides a deep dive into the process, beginning with a solid problem definition statement, which is determined with data that can be used to verify the effectiveness of the implemented solution. Using workshops, case studies, and simulations, in this course you’ll work through the entire root cause analysis process, from creating a data-based problem statement, applying RC tools, and conducting data analysis for verifying the cause to selecting the best solution and determining its effectiveness.

Upcoming Dates and Locations

Virtual seminars run as 1/2-day sessions. In-person classes run as full-day sessions. See the virtual session daily class times.

Location Start Date Days Cost Public Course Private
VIRTUAL DELIVERY (Eastern Time) 07/12/2021 5 $2995.00 Add to Cart CONTACT US
VIRTUAL DELIVERY (Eastern Time) 10/18/2021 5 $2995.00 Add to Cart CONTACT US
VIRTUAL DELIVERY (Eastern Time) 12/06/2021 5 $2995.00 Add to Cart CONTACT US

What You Will Learn

At the end of this workshop, participants will be able to:

  • Identify why CAPA is required and who requires it
  • Develop a risk-based approach to the CAPA process to determine the depth of investigation, CAPA cycle time, and any immediate corrections your organization needs to take
  • Describe the benefits of creating a problem-solving culture within the organization
  • Create an effective problem statement 
  • Document CAPA findings
  • Differentiate and document known problems versus identifying those problems that require further investigation and CAPA
  • Analyze the root cause: Fishbone, 5 Whys
  • Verify the root cause, including with logic, trials, and data
  • Select, implement, verify, and maintain solutions
  • Defend the investigation
  • Prepare for an FDA inspection of CAPA

Who Should Attend

Anyone in compliance/regulatory affairs, QA/QC, manufacturing operations and document management, as well as anyone participating in root cause analysis investigations.
Virtual Days: 5
In-Person Days: 3
CEUs: 2.5

Virtual Session Details

Oriel STAT A MATRIX Virtual Instructor-Led Training (VILT) is a real-time internet-based learning experience where the instructor and learners are in separate locations. Oriel STAT A MATRIX’s VILT technology platform is designed to simulate a traditional in-person classroom experience and allows for 2-way dialogue, break-out sessions for engaged workshops and hands-on exercises, and group work using virtual breakout rooms. This provides for an engaging learning experience in which participants can connect with the content and interact with both the instructor and other classmates.

Online Training Schedule

  • This training is delivered as five consecutive half-day sessions.
  • Daily sessions run from 1:00-5:00 p.m. Eastern Standard Time.
  • This convenient half-day format allows you to balance your other responsibilities while still getting the training you need. 

Technical /Logistical Requirements

To participate in this learning, first and foremost, we need your engagement!  You will also need:

VIRTUAL CLASS TIMES Close

Public virtual seminars run daily from 1:00-5:00 p.m. ET. Seminars run on Eastern Time unless otherwise noted in the Location field.

Auditor classes that require a final exam start at 11:30 a.m. on the last day to administer the final exam.

For more information download the virtual course agenda (close this window and navigate to the top of the course page) or Contact Us.

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