21 CFR Part 11 Guidance for Electronic Records - 2018
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
A company must have specific policies and procedures in place that explicitly state responsibilities and provide guidance for implementing and using ER/ES capability.
Facilities
Location
Start date
Start date
Reviews
Subjects
- Training evaluation
- Education Management
- Education Studies
- Education and training
- Medical
- Medical Ethics
- Medical training
- Medical Trials
- Healthcare
- Health 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: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. This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do.
Areas Covered in the Session:System Risk AssessmentGAMP 5 "V"Model21 CFR Part 11Electronic Records/Electronic Signatures (ER/ES)Security, Access, Change Control and Audit TrailPolicies and Procedures
Who Will Benefit:Information Technology (IT) AnalystsIT DevelopersIT Support StaffQC/QA Managers and Analysts
Speaker Profile:Carolyn (McKillop) Troiano has more than 35 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs.
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=501843LIVE?channel=emagister_Jun_2018_SEO
Additional information
21 CFR Part 11 Guidance for Electronic Records - 2018
*Indicative price
Original amount in USD:
$ 150