YOU FOUND A ROOT CAUSE.

But can you prove it’s the right one?

A strong CAPA requires more than an explanation. It requires a clear path from the problem to the process, the root cause and an action that can be verified.

EXPLORE THE WORKSHOP →

THE REAL WORK STARTS

BEFORE

THE CORRECTIVE ACTION.

What happened?

Where in the process did it happen?

What conditions allowed it to happen?

and,

What needs to change so it does not happen again?

This workshop uses Lean problem-solving principles to work through those questions systematically, from defining the problem and mapping the process to identifying root causes, developing corrective actions and confirming results.

DON’T JUST CLOSE THE CAPA.

BUILD THE CASE BEHIND IT.

A PRACTICAL WAY THROUGH CAPA

WORK THE PROBLEM, STEP BY STEP.

DEFINE

Frame the

problem clearly.

TRACE

Examine the process and identify non-value-added activities.

FIND

Move beyond “human error” to identify the underlying root cause.

FIX

Develop corrective actions and confirm the results.

THE QUESTION ISN’T JUST

“WHAT CAUSED THE DEVIATION?”

IT’S

“WHAT IN THE PROCESS NEEDS TO CHANGE?”

WHO SHOULD ATTEND

QUALITY ASSURANCE

INTERNAL AUDIT

REGULATORY COMPLIANCE

For professionals across pharmaceutical, biotechnology, medical device and other regulated environments, and anyone looking to strengthen their practical understanding of CAPA.