FDAnews
Falls Church, VA (PRWEB) February 20, 2014
Drug and Device Recalls Bootcamp
**Presented by FDAnews**
April 29-30, 2014 – Bethesda, MD
http://www.fdanews.com/DDRecallsBootcamp
Who knows when the day will come that a product faces a recall? It could be tomorrow, next week or a year from now.
Sadly, many firms are complacent about recalls — and woefully unprepared.
Is the company recall plan up-to-date? Or is it an old one, in a dusty binder somewhere on a shelf — or buried deep in the SOPs archives?
When was the last time the recall plan was reviewed? Does it meet the FDA’s evolving standards for recalls? Has it ever been tested with a mock audit?
If the answer is "no" or "I don't know" to any of these questions — or if a company believes in the need to be proactive and prepared — plan to attend the FDAnews conference Drug and Device Recalls Boot Camp on April 29-30 in Bethesda, MD.
This is a must-attend event for those responsible for their organization's recall readiness. In two action-packed days of expert presentations and enlightened discussions, attendees will learn:
- The most common and simple mistakes FDA finds in recall programs
- The top 5 reasons internal recall committees fail — and how to fix them
- How to put an internal recall committee through a “mock recall” to identify strengths and weaknesses — and tips on how to shore up the program
- The specific kinds of information companies should supply the FDA to make a recall run more smoothly
- How and why the company must measure and document the financial and other costs of a recall
- Tips to help build procedures that will appropriately link a recall strategy to corrective and preventive action strategy
- And much more
After two days of "total immersion" in recall readiness, attendees will return to your office with proven best practices and tools that will ensure a recall program will run smoothly. And, attendees will be ready to confidently communicate about the program with the FDA and stakeholders.
Who Will Benefit
- Quality assurance/Quality control
- Regulatory affairs
- Legal and compliance officers
- Executive management
- Risk management specialists
- Operations and manufacturing professionals
- General/corporate counsel
- Media and public relations professionals
- Medical affairs
Meet Your Conference Chairman
David Elder is Vice President of Strategic Compliance Services at PAREXEL Consulting. He served as the Director of the Office of Regional Operations (ORO) within the Office of Regulatory Affairs (ORA), where he managed a team of professionals working around the globe to ensure that regulated products met the FDA’s standards, rules and regulations. Previously, Mr. Elder was Director of the Office of Enforcement within ORA. Prior to this position, he served in the FDA’s New England District Office as an investigator, compliance officer and as Director of the Compliance Branch.
Conference Speakers
- Heath Rushing, Principal Consultant, Adsurgo LLC
- Julianne McCullough, Recall Coordinator, Philadelphia District Office, ORA, FDA (invited)
- Kevin Morrow, Recall Coordinator, Baltimore District Office, ORA, FDA (invited)
- Ronny Brown, Chief, Recall Branch, Division of Risk Management Operations, Office of Compliance, CDRH, FDA (invited)
- Marialuisa (“ML”) Gallozzi, Partner, Covington & Burling
- Suzan Charlton, Special Counsel, Covington & Burling
- James Johnson, Associate, Hogan Lovells; former Associate Chief Counsel in the FDA’s Office of the Chief Counsel
- Sunni Churchill, Senior Director, Regulatory Affairs, US Generics, Teva Pharmaceuticals
- Joe Falvo, Senior Manager, Post Market Risk Management , Ortho Clinical Diagnostics
- Rita Hoffman, Principal Consultant, Regs & Recall Strategies, LLC; former Branch Chief, Recalls, CDRH, FDA
- Todd Halpern, Assistant General Counsel, Regulatory Law, Pfizer
Conference Details
Drug and Device Recalls Bootcamp
**Presented by FDAnews**
April 29-30, 2014 – Bethesda, MD
http://www.fdanews.com/DDRecallsBootcamp
Tuition: $1,797
Easy Ways to Register
Online: http://www.fdanews.com/DDRecallsBootcamp
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.
