2013-12-03 23:40:12 - Leverage New Tools for Device CAPA Compliance
**FDAnews Virtual Conference**
Dec. 19, 2013 — 10:00 a.m. – 4:00 p.m. EST
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/DeviceCAPAVCPR5.
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:
• QA/QC staff
• Legal and regulatory affairs
• Risk management and design operations
• Compliance officers
• Executive management
• In-house counsel
• Outside counsel
$1,297 per site -- includes virtual conference registration and audio cds and transcripts
Easy Ways to Register
By phone: 888-838-5578 or 703-538-7600
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.