21 CFR Part 11 Guidance for Electronic Records - 2018

Training

Online

£ 118.95 VAT inc.

*Indicative price

Original amount in USD:

$ 150

Description

  • Type

    Training

  • Level

    Advanced

  • Methodology

    Online

  • Class hours

    2h

  • Duration

    1 Day

  • Start date

    Different dates available

  • 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

Online

Start date

Different dates availableEnrolment now open

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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

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

Overview:This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability.
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

http://www.compliance4all.com/control/w_product/~product_id=501843LIVE?channel=emagister_Jun_2018_SEO

21 CFR Part 11 Guidance for Electronic Records - 2018

£ 118.95 VAT inc.

*Indicative price

Original amount in USD:

$ 150