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How to Comply with 21 CFR 11 Requirements

Event Details

How to Comply with 21 CFR 11 Requirements

Time: May 2, 2018 from 10am to 11:30am
Location: California
Street: 161 Mission Falls Lane, Suite 216,
City/Town: Fremont
Website or Map: http://www.compliance4all.com…
Phone: 18004479407
Event Type: webinar
Organized By: Adam Fleming
Latest Activity: Mar 12, 2018

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Event Description

Overview:
In this webinar would apply to computerized systems that
create source documents (electronic records) that satisfy the
requirements in 21 CFR 312.62(b) and 812.

Areas Covered in the Session:
What are source documents and why are they important?
(FDA and ICH GCP E6 Guideline)
What are required characteristics for source documents?
What is 21 CFR Part 11?
How can you apply 21 CFR 11 and ICH E6 to source
documents?
How EMR Data is used in Clinical investigations
How to plan electronic source document deficiencies

Who Will Benefit:Investigators
Clinical Research Coordinators
Device and Drug Study Clinical Research Associates
Clinical Research Associate Managers
Project Managers
Quality Assurance Personnel
Regulatory Affairs Personnel

Speaker Profile:
Angela Bazigos Seasoned Executive with 40 years of
experience in the Life Sciences & Healthcare Industries.
Positions include Chief Compliance Officer
http://morflearning.com/angelabazigos/. Experience
combines Quality Assurance, Regulatory Compliance,
Business Administration, Information Technology, Project
Management, Clinical Lab Science, Turnarounds and
Business Development.

Event Fee: One Dial-in One Attendee Price: US$150.00

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support@compliance4All.com

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