Software Validation Program That will Satisfy FDA Requirements - 2017

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Category FDA Inspections, Software Validation, Quality assurance, FDA Webinars, Risk analysis, Regulatory Affairs Courses Online, masters in regulatory affairs, Online trainings on Fda, software product, development of medical devices, design control

Deadline: June 07, 2017 | Date: June 08, 2017

Venue/Country: Online, U.S.A

Updated: 2017-04-24 18:34:14 (GMT+9)

Call For Papers - CFP

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 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.

Contact Detail:

Compliance4All DBA NetZealous,

Phone: +1-800-447-9407

Email: supportcompliance4All.com