Medical Device CAPA Training: Optimizing Your Programs

Can't travel? This class is also available virtually.

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 endanger patient safety, cost money, and steer internal focus away from other issues.

In this course, you will learn how to optimize your CAPA program by addressing common issues at the program level (e.g., improving timeliness, connecting CAPAs, and leveraging trending), the action level (e.g., addressing human error, applying interim actions, and verifying the effectiveness of CAPA actions), and the problem level (e.g., identifying the root cause, correcting it, and fixing the symptoms).

This class is only available for private team training. For public training, see our related course CAPA and Root Cause Investigation Training for Medical Devices to learn how to identify and define the problem, AND then solve it.

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Course Dates

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.

There are currently no public dates scheduled. All our courses are available to be held at a location of your choice. Please contact us for more information.

Course Details

What You Will Learn

At the conclusion of this workshop, you will be able to:

Explain CAPA methodology, including roles, inputs, and metrics/sources of data.
Learn best practices for how to integrate your CAPA program into your quality system.
Understand FDA’s and other regulatory officials’ expectations for “what CAPA is” and the steps required to get you there.
Learn how CAPA can positively impact the bottom line.
Understand how to differentiate and document known problems versus identifying those problems that require further investigation and CAPA.
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.
Perform basic root cause analysis, including problem definition and effectiveness checks.

Who Should Attend

Recommended for management, and staff in compliance/regulatory affairs, QA/QC, manufacturing operation, and document management.

Virtual Class Days

4 Consecutive half-day sessions. Daily sessions run from 1:00-5:00 p.m. Eastern time.

Virtual Half-Days

4
In-Person Full-Days

2
CEUs

1.5

Virtual Session Details

Oriel STAT A MATRIX virtual instructor-led training (VILT) is a real-time internet-based learning experience in which 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 dialogue, participatory 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 four consecutive half-day sessions.
Daily sessions run from 1:00-5:00 p.m. Eastern 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:

PC or MAC Computer
Reliable Internet
Video Webcam
Headset or Earbuds
Quiet Setting
Two MonitorsRecommended

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Medical Device RA/QA

Quality System Audits for ISO 13485, FDA QSR, MDSAP

Performance Excellence

ISO 9000 & Related Standards

Connected Medical Devices, SaMD & IoMT

Medical Device CAPA Training: Optimizing Your Programs

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