Historical Perspective of the Part 11 Regulation
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 will help you understand in detail the application of FDA's 21 CFR Part 11 guidance on electronic records/electronic signatures (ER/ES) for computer systems subject to FDA regulations.
Facilities
Location
Start date
Start date
Reviews
Subjects
- Project
- Perspective
- Compliance
- Health Management
- Management
- Education Studies
- Quality
- Healthcare
- Technology
- Medical
- Organizational Skills
- Clinical Studies
- Knowledge management
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:Documented Part 11 training, as with any FDA regulation, is required for staff members who have responsibilities within the scope of the regulation.Understanding the requirements of Part 11 is critical to compliance with the regulation.Knowledge of regulatory requirements is an exercise in efficiency both efficiency in project management, and avoidance of non-compliance penalties.
Areas Covered in the Session:History and OverviewSubpart A: General ProvisionsSubpart B: Electronic RecordsSubpart C: Electronic SignaturesScope & Application GuidanceQuestions and Answers
Who Will Benefit:Project/Strategic ManagementIT StaffOperations StaffQuality Assurance Staff
Speaker Profile: Angela Bazigos is the CEO of Touchstone Technologies Inc. She has degrees in Microbiology and Computing and 40 years of experience in the Life Sciences, Healthcare & Public Health Services. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety & Turnarounds.
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
Historical Perspective of the Part 11 Regulation
*Indicative price
Original amount in USD:
$ 150