FDA's 21 CFR 11 Add-On Inspections - Recent Updates

Short course

Online

£ 118.64 VAT inc.

*Indicative price

Original amount in USD:

$ 150

Description

  • Type

    Short course

  • Level

    Advanced

  • Methodology

    Online

  • Class hours

    2h

  • Duration

    1 Day

  • Start date

    October

  • Virtual classes

    Yes

At the beginning of the initiative FDA made it very clear that Part 11 is in effect and is enforced according to the original Part 11 and the Guidance from 2003.

Facilities

Location

Start date

Online

Start date

OctoberEnrolment now open

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Reviews

Subjects

  • Knowledge
  • Compliance Trainings
  • Healthcare
  • Medical courses
  • Online Trainings
  • Compliance education
  • Industrial courses
  • Technical courses
  • Fda inspections
  • Financial updates

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:

In December 2010 FDA started the Part 11 inspection initiative. While originally the initiative was supposed to last 3-6 months, it has now turned into an ongoing program with Part 11 related issues being part of most future inspections. At the beginning of the initiative FDA made it very clear that Part 11 is in effect and is enforced according to the original Part 11 and the Guidance from 2003. In the meantime FDA officials reported about key findings. For example, George Smith who heads up FDA's Part 11 working group gave an update with examples of violations.

This presentation will cover the scope, status and results of the surveillance inspections and what they may mean for the future of 21 CFR Part 11. This will enable you to determine whether your company is subject to the most common violations so you can take action to have a better inspection outcome.

Why should you Attend: In December 2010 the FDA changed the way it does audits to include 21 CFR 11 add-on inspections. Very little is known about this, yet the FDA has already issued citations on the subject. This Webinar will present the latest on FDA thinking (with slides directly from the FDA's Office of Compliance), discuss how these inspections will impact both your company and the industry, and provide guidance on how your company can ensure that they have a successful inspection.

Areas Covered In the Session:

  • What is FDA's most current thinking related to computers and electronic records?
  • What are the inspection trends?
  • What are most frequent recent citations for Part11?
  • What are the most frequent deviations for computer system validation?
  • Under which circumstances can inspectors exercise enforcement discretion?
  • How important is risk based Part11 compliance?

Who Will Benefit:
  • Everybody Using Computers in FDA Regulated Environments
  • IT Manager and Staff
  • QA Managers and Personnel
  • Regulatory Affairs
  • Training Departments
  • Consultants
  • Validation Specialists

Additional information

https://www.compliance4all.com/control/w_product/~product_id=502175LIVE?channel=emagister_Oct_2018_SEO

FDA's 21 CFR 11 Add-On Inspections - Recent Updates

£ 118.64 VAT inc.

*Indicative price

Original amount in USD:

$ 150