FREE ON-DEMAND WEBINAR

Corrective Action Preventive Action (CAPA) vs. Preventive Action Corrective Action (PACA):
Which is the smarter approach?

What is the single most common cause of 483 observations and warning letters from FDA? Corrective Action Preventive Action a.k.a. CAPA – in fact, 12.4% of all 483 observations have been from CAPA’s alone! Even more discouraging: CAPA’s, Design Controls and Complaints combined have led to ~35% of all medical device 483 observations and this “trend” has remained the same for the of past 16 of 17 years! How do we explain this?

Many are familiar with Einstein’s definition of insanity: doing the same thing over and over again and expecting a different result. However, here is a slightly different definition more applicable here: repeating the same mistakes over and over again and expecting a different result. Regrettably, the statistics above fit Einstein’s definition perfectly.

Many think that practice makes perfect. But it is not true: perfect practice makes perfect! If we continue to practice making the same mistakes, we will get very good at making those same mistakes. The statistics above demonstrate that the medical device industry has gotten very good at making the same mistakes over and over and over again!

This webinar will take a critical approach to the CAPA process including:

• What are the most common reasons FDA issue’s 483 Observations and Warning letters?
• What is a CAPA and when should a CAPA be used or not used?
• What are common reasons for 483's/warning letters involving CAPA's?
• How do you know if your CAPA system is working?
• How are CAPA's related to other parts of your QMS, e.g., risk, post-market surveillance, complaint handling, etc.?
• When should a complaint initiate a CAPA?
• Why do we call a CAPA a CAPA? Is the PACA a better approach?

In this webinar, participants will learn best practices to avoid timely and costly mistakes and creative ways to use CAPA’s (and PACA’s) to their advantage! CAPA’s are a vital and required component of all medical device company’s quality management system (QMS0, yet most of them are very poorly written and are a common source of problems in FDA inspections often leading to 483 observations, warning letters or worse!

Simply put: we do not need more regulation or guidance to solve problems like these… we need more people thinking and understanding the regulation and guidance we already have (i.e., regulatory logic) and applying it properly!