Loading ...

Public Training Course Dates & Information:

Course Catalog PDF Download Catalog ยป
On-site TrainingOn-site Training

A customizable, cost-effective solution for groups of 5 or more. Contact us to learn more »

On-site TrainingGroup Discount Save up to 25%

Enroll three students in the same course (held on the same date and at the same location) at the regular price and receive a fourth enrollment for free. *This offer cannot be combined with any other promotional offer(s).

Medical Device CAPA Training: Optimizing Your Programs

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).

Upcoming Dates and Locations

Please Contact Us if you need additional information or if you don't see a date that works for you. To register by phone, call 1.800.472.6477  |  On-Site training available, learn more »

Location Start Date Days Cost Public Course On-Site
Boston, MA 07/22/2019 2 $1995.00 Add to Cart CONTACT US
San Francisco Area, CA 08/05/2019 2 $1995.00 Add to Cart CONTACT US
Orlando, FL 09/16/2019 2 $1995.00 Add to Cart CONTACT US
San Diego, CA 09/30/2019 2 $1995.00 Add to Cart CONTACT US
Minneapolis, MN 10/21/2019 2 $1995.00 Add to Cart CONTACT US
Edison, NJ 11/11/2019 2 $1995.00 Add to Cart CONTACT US
Chicago, IL 12/09/2019 2 $1995.00 Add to Cart CONTACT US
Boston, MA 01/06/2020 2 $1995.00 Add to Cart CONTACT US

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.

Number of Days: 2
CEUs: 1.5
On-Site Training Close

The dates you choose. The location you want.
The results you need!

Bring any of our classes to your location - Oriel STAT A MATRIX on-site training is the perfect solution for training groups of five or more employees or launching a companywide training effort. It's cost-effective, completely customizable, and absolutely hassle-free. For more information, call 1.800.472.6477 or Contact Us.

Get answers right now. Call 1.800.472.6477