Validation for the New FDA Inspections

Overview:

How to conduct a software validation program that will satisfy FDA requirements and produce a safe product.

Why should you Attend:

There are additional requirements,analyses and tests that FDA feels are necessary to prevent user injuries. These requirements were developed after analysis by the FDA of many recalled medical devices. In this webinar you will learn the requirements in addition to functional tests that are required to produce a validated software product. 

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

Event Fee: One Dial-in One Attendee Price: US$150.00

Contact Detail:

Compliance4All DBA NetZealous,

Phone: +1-800-447-9407

Email: support@compliance4All.com

Speaker Profile:

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. Mr. Waldbusser has a BS in Mechanical Engineering and an MBA.