Developing and Validating Software for the Medical Device Industry
Program At-A-Glance |
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Day One: 8:00 AM - 5:00 PM |
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Day Two: 8:00 AM - 5:00 PM |
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Day Three: 8:00 AM - 5:00 PM |
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Three day workshop provides attendees with guidance on designing software validation plans that build confidence in the software and comply with regulatory requirements. The workshop is exercise-driven to allow attendees to apply appropriate validation tools and techniques for embedded device software, off-the-shelf software, and quality system (non-device) software course. Case studies on traceability analysis, requirements writing, test designs, and validation planning give examples and possible solutions to validation activities.
Workshop Goals
At the end of this workshop, participants will be able to:
- Design software validation plans that build confidence in the software and comply with regulatory requirements for Device, Commercial Off-The-Shelf, and Quality System Software
- Use risk management to focus validation activities to minimize risk
- Streamline elements of the Quality System for cost-efficient software development and validation
- Select appropriate lifecycle models and synchronize validation activities for all types of software
- Write unambiguous, testable requirements
- Integrate best development engineering practices to support validation efforts
- Organize test designs, test cases, and test procedures that effectively cover requirements being verified, and that provide opportunities for review and management of the process.
Format
This 3-day workshop provides intensive coverage of the elements of software validation from an engineering and quality perspective. This highly interactive workshop includes a variety of exercises that cover validation activities at various points throughout the software lifecycle. These exercises provide participants with the opportunity to apply new information to actual software validation scenarios.
Who Should Attend?
This course is intended for those who perform hands-on validation activities—R&D team members, design engineers, software developers, testers, project/program managers, process engineers. For those who require an understanding of regulatory requirements, it is recommended you attend the Regulatory Requirements for Software Validation in the Medical Device Industry course.
Dates and Hotels
| DATE | LOCATION | PHONE & RATES |
| June 10-12, 2013 | Eden Roc Renaissance Miami Beach 4525 Collins Avenue Miami Beach, FL 33140 Website |
888-236-2427 $199 single/double Rate though: 5/12/2013 |
| October 9-11, 2013 | The Westin Casuarina Las Vegas Hotel, Casino & Spa 160 East Flamingo Road Las Vegas, NV 89109 Website |
866-837-4215 $170 single/double Rate through: 9/13/2013 |
| NOTE: Reservation request should be made as soon as possible, but no later than the 'rate through' date listed above. Rooms are assigned on a first-come, first-served basis and may sell out prior to the deadline. | ||
Fee and Registration
Fee includes PowerPoint presentations and case studies; Dave Vogel “Medical Device Software: Verification, Validation and Compliance”; relevant standards and/or technical information reports; pertinent FDA documents and additional references; and continental breakfast, lunch, and refreshments. Click here to go to registration.
| REGISTRATION TYPE | FEES |
| AAMI corporate and institutional members | $1835 |
| AAMI individual members | $1935 |
| Nonmembers | $2235 |
| Government Employees | $635 |