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Risk Management Through Product Life Cycle: An Educational ForumThis was another installment of FMDIC's popular series of educational forums on the medical device Quality System Regulation (QSR) mandated by Title 21 of the Code of Federal Regulations, Part 820 (21 CFR 820).
The goal of the workshop was to present information that will enable manufacturers and regulated industry to better comply with the Medical Device QSR. The following topics were discussed at the workshop (see draft agenda for more details):
Date & TimeThis educational forum was held on Friday, April 2, 2010, from 8:30 AM to 5:00 PM. There was no onsite registration on the day of the event. VenueThe event was held at
the New Cowboys Stadium in Arlington,
Lot 10, Entry K (northwest corner of the stadium), 900 E Randol Mill Rd., in Arlington, Texas
76011 [Directions]
[Map Our space was on the Cowboys Club North on the Main Concourse, next to Entry
K. [Diagram RegistrationRegistration for this event was closed early due to capacity. No onsite registrations on the day of the event were permitted.
Early Registration ended on March 19, 2010, at midnight central time. Paid registration included continental breakfast, lunch, refreshments throughout the day, a pocket sized 21 CFR 820 (Quality System Regulation) booklet, and a tour of the new Cowboys Stadium. To review or change an existing registration information or update your profile, please click here. Cowboys Stadium TourRegistration included an optional tour of Cowboys Stadium at no extra charge. The online registration provided a questionnaire that asked if planning to take the tour. To review or change a response to the registration questionnaire, please click here. AirportsDallas/Fort Worth International Airport (DFW) is the closest airport to the venue and the lodging recommendation. For more information, please visit http://www.dfwairport.com/. Ground TransportationIf you choose to stay at our lodging recommendation, the Sheraton Arlington Hotel, you may choose to use their courtesy shuttle from DFW Airport. Other choices are listed in the DFW Airport web site at http://dfwairport.com/transport/index.php. LodgingFMDIC negotiated a limited number of rooms at a special discount rate starting at $129 per night at the Sheraton Arlington Hotel, located at 1500 Convention Center Drive. This block of rooms was been exhausted, but the hotel still had rooms outside this block and offered other discounts. This hotel's phone number is 817-261-8200 or toll-free 800-325-3535. [Directions] There are several other fine lodging options near the new Cowboys Stadium in Arlington. ParkingThe new Cowboys Stadium in Arlington is HUGE. Use parking lot 10 and
entrance K of the stadium (see
site plan Dress CodeThe dress code was casual (Dallas Cowboys attire welcomed). We recommended dressing in layers and bringing jackets for comfort. WorkbookThe workbook for this event is available online for registrant download. The file is a 1.4 Mb Portable Document Format (PDF) file that requires Adobe Acrobat Reader 8.0 or better in order to properly open and print. This software is available online at http://get.adobe.com/reader at no cost. If this file is too large for your system to download, you may opt to download the individual presentation handouts from the agenda web page. Make sure you save a copy of each file you download in a local drive for future use offline. Hardcopy workbooks were not be distributed at this event. ComputersThe venue offers wireless access to the internet during the event. However, the space used has a very limited number of electrical outlets to accommodate notebook computers. These were available on a first-come/first-served basis. LunchA buffet lunch, coffee, and other refreshments were included with registration. ADA/AccessibilityCowboys Stadium is committed to guests with disabilities. Their facilities are fully accessible and they provide a wide range of services and amenities for guests with special needs. Cowboy Stadium is designed with accessible parking, accessible vehicle drop off areas, power assisted doors, restrooms, concessions, water fountains, ATMs, and seating areas. SmokingIn accordance with City of Arlington regulations, smoking is PROHIBITED IN ALL AREAS OF THE STADIUM. Guests wishing to smoke may do so only in designated smoking areas outside entry K. Violators of this policy may be ejected from the stadium. Area AttractionsThe City of Arlington is happy to welcome you and has put together a flier with offers just for you. Six Flags Over Texas is nearby with fun for the whole family. The park was open on April 2 and 3 from 10 AM to 10 PM, and on April 4 from 11 AM to 7 PM. The Texas Rangers played at the Rangers Ballpark in Arlington (right around the corner from Cowboys Stadium) against the Kansas City Royals on April 2 at 7:05 PM. ContactFor questions or special needs, contact David Arvelo at david.arvelo@fda.hhs.gov or 214-253-4952. Requests for special accommodations for disabilities must be made by no later than 14 days prior to the event. We recommend you become a fan of the FDA Medical Device Industry Coalition on Facebook to find out about the latest information quicker. We also have a group in LinkedIn. FDA Medical Device Industry Coalition on Facebook
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