How to Comply with 21 CFR 11 Requirements


Originalpreis in USD:
$ 150

Wichtige informationen

Tipologie Workshop
Niveau Advanced
Methodologie Online
Unterrichtsstunden 2h
Dauer 1 Day
Beginn nach Wahl
Virtueller Unterricht Ja
  • Workshop
  • Advanced
  • Online
  • 2h
  • Dauer:
    1 Day
  • Beginn:
    nach Wahl
  • Virtueller Unterricht

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

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 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

Einrichtungen (1)
Wo und wann
Beginn Lage
nach Wahl
Beginn nach Wahl

Was lernen Sie in diesem Kurs?

Quality Assurance
Medical Science
Clinical Research
Quality Training
Course organisation


This webinar also applies to recorded source data transmitted from automated instruments directly to a computerized system (e.g., data from a chemistry autoanalyser or a Holter monitor to a laboratory information system). This webinar also applies when source documentation is created in hardcopy and later entered into a computerized system, recorded by direct entry into a computerized system, or automatically recorded by a computerized system (e.g., an ECG reading). The webinar does not apply to computerized medical devices that generate such data and that are otherwise regulated by FDA.

Zusätzliche Informationen

Compliance4All DBA NetZealous161 Mission Falls Lane, Suite 216,Fremont, CA 94539, USA. Phone: +1-800-447-9407Email: