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SPECIALITES MEDICALES ...

How software requirements are used in validation

Du Mardi 30 Janvier 2018 au Mardi 30 Janvier 2018 à CA
A partir de: 10:00
Secteurs concernés: Biotechnologie -Informatique médical -
DESCRIPTION
Overview:
This course is NOT a programming course. We will discuss what must be done but will not discuss methods to execute necessary testing.

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

PUBLIC, SECTEURS, ACCREDITATION
Accréditations : 0
Public concerné: Grand Public
Audience: Internationnale
Visiteurs/Participants: 100
Conférenciers: 1
Exposants: n.r
Type d'événement: Conférences en ligne
Secteur principal: BIOTECHNOLOGIE
Secteurs concernés: Biotechnologie -Informatique médical -
ORGANISATEUR / ANNONCEUR

COMPLIANCE4ALL
161 Mission Falls Lane, Suite 216,
94539 Fremont
UNITED STATES

COMMENT
REFERENCE
Congrès, formations ou conférences médicales REF #28-7704
How software requirements are used in validation
Publié sur congres-medical.com le : 2017-11-14 13:48:08
Congrès, formations ou conférences médicales en BIOTECHNOLOGIE
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