Leverage New Tools for Device CAPA Compliance

 

Years after CAPA became a compliance standard for device manufacturers, its complexities still bedevil manufacturers. CAPA remains the No. 1 violation cited in medical device audits.

CAPA regulations are complex and can be confusing. What the FDA wants, despite being described in the QSIT, is still a mystery to many. Competitors rarely share compliance success stories. And as an FDA investigator pours over your SOPs and case files, who knows what he or she will find?

Ever wonder what the gold standard in device CAPA management looks like? We’ll show you.

Make sure you’re on hand on Thursday, Dec. 19, when a panel of experts spend a day taking CAPA apart … then putting it back together — the right way.

Register now for Leverage New Tools for Device CAPA Compliance, a “virtual conference” presented by FDAnews.

You’ll get the inside view from a former FDA inspector. With 28 years inspecting premises like yours, Ken Miles knows FDA’s playbook inside and out. What the agency tells investigators to look for in your CAPA files? Which seemingly small mistakes can balloon into catastrophes? Mr. Miles has seen it all … and now he shares it all.

Greg Meyer will then discuss how to behave ethically and scientifically when analyzing a limited number of data points when preforming an error analysis on your CAPA systems and failure investigations.

Then it’s on to nuts and bolts, with roll-up-your-sleeves compliance sessions featuring Jason Spiegler, Director of Strategic Market Development at Camstar Systems and Dan O’Leary of Ombu Enterprises. You’ll dig into the nitty-gritty of CAPA compliance … learn how to secure executive buy-in for developing state-of-the-art CAPA programs … and discover specific, proven ways to boost profits via an improved CAPA program.

Want specifics? Here’s a laundry list:

• What the FDA inspector looks for: the insider’s checklist
• Red flags that trigger a more thorough inspection
• Key procedures that ensure CAPA success
• Specific value metrics medical device manufacturers have benefited from after implementing improved CAPA compliance programs
• How to develop a truly proactive CAPA program
• Making strategic investments in CAPA without breaking the bank
• Getting executive buy-in for instilling a new proactive CAPA philosophy
• And much more!
   

You’re bound to have questions during this six-hour event. That’s no problem — the virtual conference is 100% interactive. Submit questions in real time via email. You’ll have answers by the time the session ends.

And here’s more good news: Enlist your entire team at no extra cost. One low registration fee covers every participant at one location. It’s easy to add additional locations, too, at bargain rates. Simply call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally to learn about multisite discounts.

If you are a device manufacturer or application developer, diagnostic company, or outside counsel representing FDA-related firms subject to CAPA, this virtual conference is a godsend. Why delay? Register now.