Hear directly from a senior executive in FDA’s
Center for Devices and Radiological Health!
The FDA is increasingly finding alarming problems with training at device facilities. During an inspection, agency investigators not only check whether a company has a training program, but assess its adequacy. Companies increasingly lack a written training program, or the program really doesn’t cover the fundamentals. Sometimes the employee isn't trained on a timely basis, or has no training at all.
How can you ensure your training program meets FDA expectations by having detailed procedures and clear training plan for employees? Are you teaching workers about the Quality System Regulation? How do you train new employees and conduct refresher courses for current workers?
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 device quality system warning letters.
At this exciting new webinar, you’ll learn how to assess your existing training processes and ensure that you have an adequate training program. Identify what needs to be done to pass an FDA inspection. Learn what strategies other device manufacturers are pursuing to verify and validate their training processes. Analyze training violations cited in FDA warning letters and learn what not to do, and get practical, real-world advice on what steps are necessary to maintain an adequate training program. All this, and more, is yours when you register to attend FDA Requirements for Training at Device Facilites: Are You in Compliance?
Learn how to:
- Include the most critical components to a training program
- Organize a comprehensive SOP for training processes and documentation
- Analyze some common employee training violations
- Select "sufficient" personnel with appropriate skills
- Determine a potential employee’s training needs
- Communicate QSR requirements in different ways
- Select well-qualified trainers
- Handle employee orientations
- Teach new employees about FDA’s expectations under the Quality System Regulation
- Handle CAPAs and complaints
- Train employees about FDA inspections
- Keep up-to-date training records
- Communicate procedure changes to employees
- Ensure training efficiency
... and much more!
The discussion will be delivered in a convenient audio conference format, and capped off with an interactive Q&A round.
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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CASPER E. ULDRICKS is the Associate Director for Regulatory Guidance and Government Affairs at the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH). He manages the implementation of the Federal Food, Drug, and Cosmetic Act, as amended, for medical devices, and the development of guidance and regulations for the agency’s device program. He is recognized as FDA’s expert in the interpretation and application of several statutory provisions.
Prior to his current position, he served for 10 years as the senior special assistant to the Director of the Office of Compliance in CDRH. He also served for five years as the Congressional Liaison in FDA's Office of Legislative Affairs for FDA’s medical device program and served as a Public Health Advisor in the U.S. House of Representative's Small Business Subcommittee on Regulation, Business Opportunity, and Technology under the LEGIS Fellows Program. He began his FDA career in 1978 as an investigator in Boston, Massachusetts.
Mr. Uldriks has contributed to medical text books concerning FDA’s regulation of medical devices and has been a featured speaker at numerous FDA, professional, and trade association conferences.
He earned his J.D. in 1986 from Suffolk University, his Master of Divinity from Boston University in 1976, and his B.A., cum laude, in 1973 from Albion College. He is a member of the bar in the Commonwealth of Massachusetts. |
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DONALD A. MIDDLEBROOK is Vice President, Corporate Quality and Regulatory Affairs for Thoratec Corp. in Pleasanton, California. He has more than 25 years of regulatory affairs and quality assurance experience in the medical device industry. In his current capacity, Mr. Middlebrook is responsible for overseeing all regulatory, clinical and quality assurance activities for the company’s diverse product line worldwide. Thoratec is a manufacturer of cardiovascular devices including ventricular assist devices, vascular grafts and a full of hemostasis management and point-of-care products.
Before joining Thoratec, Mr. Middlebroo held the position of Senior Director, Global Regulatory Affairs and Quality Assurance for Chiron Vision, a division of Chiron Corp. involved in the manufacturing of ophthalmic surgical devices. In addition, he spent 15 years with Baxter International in a number of progressing positions including Vice President of Regulatory Affairs and Quality Assurance for the CardioVascular Group.
Mr. Middlebrook holds a B.A. degree in Biology from California State University, Fullerton. He has been actively involved in a number of professional organizations including AdvaMed and RAPS. In 2005, he was elected to the Regulatory Affairs Professionals Society (RAPS) Board of Directors and is currently serving his second term. In September 2008, Mr. Middlebrook was nominated in the inaugural class of RAPS Fellows. In addition to his experience in the medical device industry, Don has over 6 years of voluntary service as Chairman of the Saddleback Memorial Medical Foundation (SMMF) Board of Directors and as Chairman of the SMMF Executive Committee. |
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LAURENCE (Larry) KOPYTA is Quality System Business Group Partner at MEDRAD, Inc., a business of Bayer Medical Care. He has over 30 years of experience in medical devices, including management positions in research, operations, quality and regulatory at Becton Dickinson, Siemens Medical, and Fisher Scientific.
MEDRAD, a 2003 Baldrige National Quality Award recipient, is a global market leader in the design and manufacture of electromechanical and sterile disposable systems used in diagnostic imaging. In his current role, Mr. Kopyta is responsible for managing and delivering quality and compliance training across the organization, as well regulatory intelligence, standards monitoring, and managing licenses and external regulatory audits.
He holds a B.A. in Natural Sciences from Johns Hopkins University and an MBA from Loyola College. He is a member of and holds certifications from ASQ, RAPS, AAMI, and PDA and serves on a number of industry association committees. |
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What
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One
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team(s). Toll-free in the U.S. only.
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One
(1) password to a website on which you'll be taken through the
presenters' slides as they speak to them.
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An
interactive Q&A round with speakers by phone and electronic submission
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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.
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The
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– and lower cost. Your entire team can listen in one
room. No travel required!
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team approach. You've often wanted to have everyone on
your team getting the same knowledge and insight you derive from
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Interactivity. You're
remote, but not removed. Our webinars let you ask the important,
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a scheduling conflict? Don't worry — the recording is available
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Register for the live webinar, the live webinar PLUS the audio recording or the audio recording only!
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Audio recording only: $499 $399
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