2 min reading time

Even though the Corrective and Preventive Action (CAPA) process is at the heart of any quality management system, CAPA violations are the most frequently observed Quality System subsystem cited by FDA.

It happens year after year – and regardless of the devicemaker’s category or size – so I asked resident expert Jon Speer (founder of Greenlight Guru) to co-host a webinar about CAPA.

The online event is free, two weeks from today. Register at https://medgroup.biz/capa and you’ll get the slides even if you can’t attend live.

CAPA implementation and maintenance with yesterday’s systems is hard. Device makers often stumble with poor root cause determination, being reactive instead of proactive, poor definition of a CAPA process, overuse versus underuse and more.

Implementing a robust and modern approach to CAPA will lower your stress level. Well, I think so, anyway. I’d choose preparation over reaction any day.

During this free webinar, you’ll learn:
• How to avoid the most common problems with CAPA
• A best practice, step-by-step guide to implementing a modern CAPA process
• How CAPA connects to your other QMS processes
• The impact of risk management on CAPA
• How you can switch to being more preventative to catch issues before they happen

Who should attend:
• Device executives
• CAPA managers plus anyone who participates in your company’s CAPA board
• Regulatory affairs
• Quality
• Clinical affairs
• R&D engineers

Find out for yourself why Jon is consistently rated among our best and most knowledgeable speakers.

As a bonus, all who attend the live event will get a $100 coupon off Jon’s in-person workshop at the 10x Medical Device Conference in April (New Jersey). Learn more at https://medgroup.biz/10x.

And visit https://medgroup.biz/capa now for the December 12 webinar. See you there.

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Good group conversation: Will cybersecurity kill med device innovation? at
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Make it a great week.

Joe Hage
Medical Devices Group Leader

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Joe Hage
🔥 Find me at MedicalDevicesGroup.net 🔥
Thanks, Rob Kanzer. Jon’s based in MN so who knows? Ask him! He’ll also be in New Jersey with me in April if you can make 10x: https://medgroup.biz/10x

Roger Cepeda, JD, MBA, RAC
Medical Device and Biotech Attorney
This looks like a great topic and very much on point as it happens over and over again, including at large organizations. I look forward to learning more.

Rob Kanzer
Executive Coach | Leadership Development Expert | Keynote Speaker (617) 491.8939
Joe, Fascinating – thanks for the post. Might you suggest any speakers on this topic, for Medical Development Group in the greater Boston area? (I am a member – we often meet at Regis College in Weston, MA)

Vanessa Rivel
RAC│ Profesional Senior │ Operaciones de Calidad, Sistemas de Calidad y Cumplimiento Regulatorio │Instructora de ASQ CBA
Gracias Alvaro Viquez!

Claus Rømer Andersen
EMC & Radio Consultant for Medical Devices
Looking forward to it

Alvaro Viquez
Senior Quality Engineer/Medical Devices/CSSBB
Just in case Juan Gabriel Ruiz Gutierrez Vanessa Rivel

Mark Ceelen
Vendor Manager at Cycleon
Paul Maas and Natalia Perez