Compliance for Electronic Records and Signatures (21 CFR Part 11)
Training
Online
*Indicative price
Original amount in USD:
$ 150
Description
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Type
Training
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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
This webinar demystifies Part 11, and get you on the right track for using electronic records and signatures to greatly increase productivity, and explains about the regulation and how it applies to computerized systems.
Facilities
Location
Start date
Start date
Reviews
Subjects
- Healthcare
- Medical Trials
- Pharmaceutical
- Manufacturing
- Professional
- Medical training
- Courses
- Online Trainings
- Quality Assurance
- Compliance Trainings
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:Which data and systems are subject to Part 11What Part 11 means to you, not just what it says in the regulationAvoid 483 and Warning LettersExplore the three primary areas of Part 11 compliance: SOPs, software product features, and validation documentationEnsure 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 signatures
Who Will Benefit:ITQAQCLaboratory StaffManagersGMP, GCP, GLP Professionals
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
Compliance for Electronic Records and Signatures (21 CFR Part 11)
*Indicative price
Original amount in USD:
$ 150