Overview

You may have noticed that investigations and Corrective Actions/Preventative Actions (CAPA) are frequently listed as the top observations in regulatory inspections each year. As an industry, we don’t do well with conducting deviation investigations, discovering “Root Cause,” and implementing the right CAPA. Even if we get the first steps right, where we frequently fail is measuring the effectiveness of our CAPAs. Especially with the pharmaceutical quality system mindset established by ICH Q10, CAPA effectiveness is now an expectation, not to mention a frequent area of focus during inspections of bio/pharmaceutical companies.

In this interactive webinar, we’ll draw from CAPA effectiveness observations from the medical device world and examine what these issues will mean to your investigation process. We’ll also identify the various types of CAPAs we implement (because not all CAPAs have the same chance at being effective) to identify how a misstep earlier in the process will lead to an inaccurate CAPA and, thus, an inability to measure efficacy.

Learning objectives

What do your CAPAs tell auditors/investigators? Join this webinar to learn about:

• What the regulatory expectations say about CAPA effectiveness
• Common issues/observations related to CAPA effectiveness
• The CAPA effectiveness hierarchy, and whether you’re assigning effective or ineffective CAPAs
• What all of this means in relation to the overall deviation, investigation and CAPA process
• How to use this information to identify gaps and weaknesses in your own process

Who should attend

Anyone working in a GMP regulated environment on global or domestic scale, including quality, compliance and all management personnel from owners and contract manufacturers (CMO) will benefit greatly by attending. Anyone who works with investigating deviations, identifying/implementing/assessing CAPAs, or reviewing any of these steps of the process will also find value in this course.

How to participate

This webinar will be offered live. With your course purchase, you may participate live or view the recording at your convenience (available for 30 days)