Work with me
One is training for your team. The other is my eyes on how your NC/CAPA system is performing, and what to do about it.
In-house training
Built on what ISO 13485 and QMSR expect from your NC and CAPA process.
A few of the things we cover:
I take a limited number of in-house trainings per quarter.
Prefer email? Write to training@elevate-capa.com.
Here’s what one participant said after joining one of my trainings:
★★★★★
“I now approach NC/CAPA topics much more confidently. I can better judge when a full CAPA is actually needed and when a correction is enough. My problem statements have become sharper and more to the point.
The depth of the RCA became more risk-based now; I can better choose an appropriate RCA tool or combine them. A decision matrix for corrective actions helps to decide about the next steps. Overall, the process feels more focused and efficient.”
1:1 advisory
I have 2 advisory spots open each quarter for medical device quality leaders who want my eyes on their NC/CAPA processes.
I read how your process is defined and calculate the metrics most auditors or investigators ask for. From there you can see where your process falls short of the standards and regulations, where that leaves you with regulatory risk, and at which phase your records stall.
If you want, we can go deeper: review a sample set of your records and the other process interfaces, and build the improvement plan or the training material so your teams manage NCs and CAPAs compliantly. The goal is that you can defend the records in your next audit or inspection without second-guessing every decision.
You can start with a free CAPA Strategy Session. You get to see how I work and think, and I will understand enough about your current situation to tell you whether I can help.
Or send me a mail at georg.digel@elevate-capa.com.
“He came well-prepared, having taken the time to read about our company and understand what we do, something I don’t often experience from consultants. After a brief review of our process documents, he was able to pinpoint several gaps that were preventing us from having a streamlined procedure for NC and CAPA management. His explanations were clear, thorough, and pedagogical, which made it easy to understand how we could efficiently close those gaps.
I highly recommend seeking advice from elevateCAPA if you are a smaller business like ours looking to improve your NC-CAPA management, an area that is often misunderstood and difficult to get right.”
Maria S. — QA Manager
Start with the MedTech CAPA Journal, about twice a week: frameworks to focus on the NCs and CAPAs that matter, keep your system effective without overengineering it, and defend it in your next audit or inspection, plus opinions and a look behind the scenes of my work. The same list 500+ quality professionals already read. You’ll get the CAPA Stress Test toolkit as a welcome gift.
No fluff. Unsubscribe anytime.