Which data and systems are subject to 21 CFR Part 11
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
2h
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Duration
1 Day
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Start date
Different dates available
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Virtual classes
Yes
Learn exactly what is needed to be compliant for all three primary areas: SOPs for the IT infrastructure, industry standards for software product features, and the 10-step risk-based validation approach.
Facilities
Location
Start date
Start date
Reviews
Subjects
- Risk
- Industry
- IT risk
- Systems
- Medical
- Education Management
- Education and training
- Training project coordination
- Health Management
- Health and Fitness
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
Areas Covered in the Session:Ensure data integrity, security, and protect intellectual propertyUnderstand the current computer system industry standards for security, data transfer, and audit trailsElectronic signatures, digital pens, and biometric signaturesSOPs required for the IT infrastructureProduct features to look for when purchasing COTS software
Who Will Benefit:Quality AssuranceQuality ControlLaboratory StaffManagersGMP, GCP, GLP Professionals
Speaker Profile:David Nettleton, is an FDA Compliance Specialist for 21 CFR Part 11, HIPAA, and Computer System Validation. His latest book is "Risk Based Software Validation - Ten easy Steps" that relates to the development, purchase, installation, operation and maintenance of computerized systems used in regulated applications.
Event Fee: One Dial-in One Attendee Price: US$150.00
Contact Detail:Compliance4All DBA NetZealous,Phone: +1-800-447-9407Email: support@compliance4All.com
http://www.compliance4all.com/control/w_product/~product_id=501918LIVE?channel=emagister_Jun_2018_SEO
Additional information
Which data and systems are subject to 21 CFR Part 11
*Indicative price
Original amount in USD:
$ 150