Medical Device CAPA Training: Optimizing Your Programs

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.

Related Courses

• Medical Device Complaint Handling, Event Reporting, and Recall Management Training
• Medical Device Root Cause Analysis Training
• ISO 14971 Medical Device Risk Management Training

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:

See course dates to find / register for a virtual session of this course.