The FDA is increasingly finding alarming problems with device software, such as the continued use of aging microprocessors and platforms. How do you prevent defects, failure rates, corrective actions, liabilities and ultimately recalls from your device software?

Your best bet is to join us for a can’t-miss webinar with a panel of experts who will help you understand how to prevent potential recalls and ensure safety. 

Some companies are not following design controls, not conducting enough testing and failing to create thorough requirements documents. There have been a number of cases where companies have outgrown the microprocessor or software platform. Companies take shortcuts by making incremental changes, which are less expensive rather than starting from scratch with a new platform. Software problems then arise in all sorts of devices and increase the number of recalls and, in some cases, deaths.

At this exciting new webinar, you’ll learn how to assess your existing device software safety processes and ensure that you have sound risk management, quality management and good software engineering. Identify what needs to be done and documented to ensure the safety of your device!

Learn what strategies other organizations are pursuing to verify and validate their device software. Understand the design requirements outlined in the Quality System Regulation. Analyze sample recall situations to study verification and validation obstacles, and get practical, real-world advice on what it takes to implement a successful software validation program. All this, and more, is yours when you register to attend FDA Requirements for Device Software: Are You in Compliance?

Here’s just a sample of what you’ll learn during this comprehensive 90-minute webinar:

• What the most critical components are to a software verification and validation program
• How errors are introduced into software code
• How to satisfy design control requirements for your device software using simulation, modeling and visualization techniques
• How much testing is enough
• The appropriate amount of documentation for the software you are making
• How to conduct risk analysis for device software
• When an iPhone is a medical device, and how to determine whether your software is a medical device
• How and when an electronic health record system should be regulated

…and much more!

Sign up now for this valuable insight! For one low price (just $299 through July 15; $399 after), you and your entire team from one location can take part in this fast-paced, insightful web conference from Windhover Webinars. Best of all, you’ll be able to connect personally with our expert panelists by typing your questions into the website during the event, and when we open up the phone lines for live Q&A.

So join us, in the convenience of your own office, for a thought-provoking analysis. Grab your team (or several teams), a conference room at your office, a phone and a computer with Web access (that last one's optional). No travel required!

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	SHERMAN EAGLES retired from Medtronic in June 2008, and now does training and consulting on software standards and software risk management with SoftwareCPR, a consulting group specializing in regulated medical software. He was a Technical Fellow at Medtronic where he worked 18 years on software development, software process, software safety and software reliability in medical devices. Mr. Eagles has over 40 years of software experience, including development work on operating systems, communications systems, software development tools and software development processes. He is the convener of three international standards working groups responsible for medical device software, safety requirements for programmable electrical medical systems and risk management for IT networks that include medical devices.  He also co-chairs the Medical Device Software Committee of The Association for the Advancement of Medical Instrumentation (AAMI) with John Murray of the FDA.  He also is chair of the medical device software working group of AdvaMed and represents AdvaMed on the Global Harmonization Task Force (GHTF) software committee. Mr. Eagles received a Bachelor’s degree in physics from Macalester College.
	RAYMOND A. BONNER, a partner at Sidley Austin LLP, served as an Assistant U.S. Attorney in the District of Maryland for six years, where he prosecuted major pharmaceutical fraud and GMP cases, and litigated other FDA-related cases. He concentrates his practice on FDA and healthcare-related enforcement matters. Mr. Bonner is also a member of the firm's Executive Committee. Throughout his tenure as a prosecutor, Mr. Bonner counseled FDA and its Special Prosecution Staff investigating the health care industry and developed extensive FFDCA experience. He has substantial experience with regulatory reporting and submission requirements, good manufacturing and laboratory practices, and marketing and labeling requirements and also counsels industry manufacturers on industrial espionage matters. Mr. Bonner is the recipient of FDA's Harvey W. Wiley Medal and Commissioner's Special Citation. He received his J.D. from New York University School of Law and a B.A., summa cum laude, from the University of Maryland, and clerked for the Honorable Paul H. Roney of the Eleventh Circuit Court of Appeals.
	NATHAN C. SHEERS is a partner in the Washington, D.C., office of Sidley Austin LLP. His practice concentrates on complex civil, criminal and administrative matters. He has conducted many sensitive internal corporate investigations involving allegations of fraud and abuse against various healthcare and pharmaceutical entities, and has defended clients in related civil and criminal proceedings, including grand jury inquiries, whistleblower suits and employment matters. His practice also includes internal investigations and preparations for FDA inspections, the implementation of Good Manufacturing Practice (GMP) and the Quality System Regulation (QSR), and adverse event and medical device reporting. Mr. Sheers has represented clients before various federal district courts, Courts of Appeals and the Supreme Court of the United States, and has presented oral argument at both the trial and appellate levels. Mr. Sheers also has created and presented compliance programs and training materials designed to assist employees in compliance with relevant healthcare and FDA laws and regulations.
	ALLISON FULTON is an associate in the Food and Drug Practice in the Washington, D.C. office. Her practice focuses on FDA regulation of pharmaceuticals, biologics, and medical devices as well as regulatory issues arising under the Hatch-Waxman Act. Ms. Fulton has provided regulatory advice on matters related to advertising and promotion and has counseled clients on compliance programs. Prior to the practice of law, Ms. Fulton was a software engineer where she specialized in software validation and testing procedures. Ms. Fulton earned her law degree from the University of Texas School of Law, where she was the managing editor of the Texas Intellectual Property Law Journal.

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  What does registration get me?

• One (1) phone line, for you alone, or around which to gather your team(s). Toll-free in the U.S. only.
• One (1) password to a website on which you'll be taken through the presenters' slides as they speak to them.
• An interactive Q&A round with speakers by phone and electronic submission
• Online access to the audio and slides of the entire event if you can't attend the webinar live, and still want to hear the content.
• The insight you've come to expect and respect from Windhover Webinars and our guest speakers.

• Convenience – and lower cost. Your entire team can listen in one room. No travel required!
• A team approach. You've often wanted to have everyone on your team getting the same knowledge and insight you derive from physical conferences. Now you can.
• Interactivity. You're remote, but not removed. Our webinars let you ask the important, burning, controversial questions of our speakers that you'd be able to pose at a physical conference.
• Flexibility. Want to be able to review what you learn? No problem ... just register for the live webinar PLUS a digital copy of the entire event to listen to at your convenience. Interested in the topic but have a scheduling conflict? Don't worry — the recording is available for purchase at any time!
  
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Webinar presented by

Windhover Webinars
Elsevier Business Intelligence
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