How to Comply with 21 CFR 11 Requirements

Compliance4All

Course

Online

£ 119.90 VAT inc.

*Indicative price

Original amount in USD:

$ 150

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Description

  • Type

    Workshop

  • Level

    Advanced

  • Methodology

    Online

  • Class hours

    2h

  • Duration

    1 Day

  • Start date

    Different dates available

  • Virtual classes

    Yes

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

Facilities

Location

Start date

Online

Start date

Different dates availableEnrolment now open

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Reviews

Subjects

  • Personnel
  • Compliance
  • Quality Assurance
  • Quality
  • Project
  • Clinical Research
  • Quality Training
  • Medical Science
  • Healthcare
  • Course organisation

Teachers and trainers (1)

Adam Fleming

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

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.

Additional information

Compliance4All DBA NetZealous161 Mission Falls Lane, Suite 216,Fremont, CA 94539, USA. Phone: +1-800-447-9407Email: support@compliance4All.com

http://www.compliance4all.com/control/w_product/~product_id=501746LIVE?channel=emagister_May_2018_SEO

See related categories

How to Comply with 21 CFR 11 Requirements

£ 119.90 VAT inc.

*Indicative price

Original amount in USD:

$ 150

The best Other Health courses

See all

See all