FDAnews Announces Leverage Tools for Device CAPA Compliance Virtual Conference, Dec. 19


Leverage New Tools for Device CAPA Compliance **FDAnews Virtual Conference** Dec. 19, 2013 - 10:00 a.m. - 4:00 p.m. EST www.fdanews.com/DeviceCAPAVCPR3

Falls Church, VA (I-Newswire) December 3, 2013 - CAPA compliance traps more devicemakers than any other FDA violation, but it needn't be that way. Discover how to escape the CAPA trap.

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 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 attendees.

Be 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.

Attendees will 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 CAPA files? Which seemingly small mistakes can balloon into catastrophes? Mr. Miles has seen it all … and now he shares it all.

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. Attendees will 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!

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 essential. Why delay? Register now at www.fdanews.com/DeviceCAPAVCPR3.

Meet the Faculty
• Ken Miles is Principal, Alpha Quality Assurance. He logged 28 years as a senior FDA medical device investigator before entering the private sector.
• Jason Spiegler is Director, Strategic Market Development at Camstar Systems, and Chair, ASQ Charlotte, NC Section.
• Dan O'Leary (Chair) is President, Ombu Enterprises.

Who Will Benefit
Device CAPA Compliance is a must-attend event for every colleague, from the manufacturing floor to the test lab to the legal counsel's office to the executive suite. Here's a checklist of potential attendees:
• Manufacturing
• QA/QC staff
• Legal and regulatory affairs
• Risk management and design operations
• Compliance officers
• Executive management
• In-house counsel
• Outside counsel


Conference Details
Leverage New Tools for Device CAPA Compliance
**FDAnews Virtual Conference**
Dec. 19, 2013 - 10:00 a.m. - 4:00 p.m. EST
www.fdanews.com/DeviceCAPAVCPR3

Tuition
$1,297 per site -- includes virtual conference registration and audio cds and transcripts

Easy Ways to Register
Online: www.fdanews.com/DeviceCAPAVCPR3
By phone: 888-838-5578 or 703-538-7600

About FDAnews
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.






About FDAnews

FDAnews is the premier provider of domestic and international regulatory, legislative and business n   More..ews and information for executives in industries regulated by the U.S. Food and Drug Administration.

Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books, special reports and conferences to stay in compliance with international standards and FDA's complex and ever-changing regulations to get their products to market faster and boost profits.

The seasoned staff of FDAnews journalists is dedicated to providing the regulated community with timely, insightful and practical information.

FDAnews is here to bring you the information you need, when you need it and how you need it.Less..

Contact Information

FDAnews
Michelle Butler
300 N. Washington St.
Suite 200
22046

Tags:

risk management   FDA.   CAPA  

Published in:

Medical > Medical Products

Published On:

December 3, 2013

Print Release:

Print Release

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