Computer System Validation 2018 Fundamentals
Short course
Online
*Indicative price
Original amount in USD:
$ 150
Description
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Type
Short course
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Level
Advanced
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Methodology
Online
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Class hours
1h
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Duration
1 Day
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Start date
October
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Virtual classes
Yes
How to handle change control and the importance of audit trails, you will learn how to create and maintain good documentation that meets FDA compliance standards.
Facilities
Location
Start date
Start date
Reviews
Subjects
- Compliance Trainings
- Healthcare
- Medical courses
- Online Trainings
- Compliance education
- Industrial courses
- Technical courses
- Fda inspections
- Knowledge
- Financial updates
Teachers and trainers (1)
Adam Fleming
Event Manager
Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements. . Compliance4All has a panel of acclaimed Experts whose professional trainings help regulatory professionals and organizations in a number of ways and take them to their goal of meeting regulatory requirements.
Course programme
Why should you Attend:Validation of computer system software is completely different than validation of device software (embedded software). Attempting to conduct a CSV following device software validation concepts could result in a 483 or rejection of a product approval submission.
Areas Covered in the Session:Validation strategyRequirements documentationComplexity and risk analysisCreating a detailed test plan based on riskSupplier qualificationIQ, OQ and PQ
Who Will Benefit:Computer System DevelopersSystems Development EngineersQA/ QCLab Managers and AnalystsProduction ManagersEngineering Managers
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. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network.
Event Fee: One Dial-in One Attendee Price: US$150.00
Contact Detail:Compliance4All DBA NetZealous,Phone: +1-800-447-9407Email: support@compliance4All.com
Additional information
Computer System Validation 2018 Fundamentals
*Indicative price
Original amount in USD:
$ 150