Software Validation Program That will Satisfy FDA Requirements - 2017
This course will teach how to conduct a software validation program that will satisfy FDA requirements and produce a safe product.
Why should you Attend:
Testing software to prove that it works and has no bugs is not sufficient to obtain FDA approval. There are additional requirements,analyses and tests that FDA feels are necessary to prevent user injuries.
Areas Covered in the Session:
- Software validation more than testing
- Requirements traceability
- Risk analysis
- Unit,integration and system testing
- Algorithm validation
- Challenges to the software
- Configuration management
Who Will Benefit:
- Engineer
- Engineer management
- Software engineer
- Programmer
- Quality assurance
- Regulatory
Speaker and Presenter Information
Edwin Waldbusser is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the US and internationally in the areas of design control, risk analysis and software validation for the past 8 years.
Expected Number of Attendees
100Relevant Government Agencies
FDA, Software
Event Type
Webcast
This event has no exhibitor/sponsor opportunities
When
Thu, Jun 8, 2017, 10:00am - 11:00am
Cost
| General Admission: | $150.00 |
Website
Click here to visit event website
Organizer
NetZealous - Compliance4All
