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What is Data Integrity & Why is it important?

eLearning information

Updated Friday, July 5, 2024 at 8:57 AM

Reviews

Based on 238 participants

This course enables employees to quickly learn what Data Integrity is in a fun and interactive way.

Demo

What’s included

  • 45 to 60 minutes eLearning
  • Training certificate
  • One year of full access
  • Full transcript, subtitles
  • Quiz and other interactive elements

Difficulty

Beginner level

Topics

GMP GDP EudraLex Volume IV Medicines Act Deviations Quality Assurance QC Calibration Validation Qualification CSV Quality Culture Manufacturing Distribution Aseptic

Learning goals

  • Explain what Data Integrity is and why it is so important,
  • Understand the expectations of ALCOA in Good Documentation Practices,
  • Establish a relationship between your own behavior and the expectations of Data Integrity.

Why you should follow this eLearning

  • Experienced trainers from industry and regulatory
  • Widely recognized official training certificate
  • Easy & fun ways of learning about the GMP and GDP
  • Most eLearnings ends in a quiz, testing your knowledge

Description

Data Integrity is currently a hot topic worldwide. The issuance of warning letters by the US Food and Drug Administration (US FDA) has increased significantly and the trend continues.

Inspectors expect to see strong policies for handling data, both for written documents and digital systems. As a pharmaceutical employee, you must understand the principles of data integrity and know how best to record data.

ALCOA is recognized by national authorities as a tool to clarify expectations in good documentation practice, also known as GDocP. This course allows new employees to quickly learn how to complete documentation and make corrections using the ALCOA tool in a fun and interactive way.

Contents

  • What is Data Integrity?
    • Emergence of Data Integrity Problems
    • What is Data Integrity?
    • ALCOA
    • Digital Systems
    • Data types (including raw data)
  • What could go wrong?
    • Documentation
    • Analytical results
    • Electronic data
  • Relationship with corporate culture
    • What is Culture?
    • Three layers of culture
    • Cultural change
  • Summary, Exam & Certificate

Results

Participants who successfully complete this course will receive a certificate that they have successfully completed this course. The certificate is a digital certificate.

Frequently Asked Questions

How long do I have to complete the eLearning?

When you complete the last step in the payment process you will have 365 days to complete the eLearning before you must renew your purchase.

Do I get a certificate upon completing the eLearning?

Upon succesfully completing the eLearning you will be issued with a GMP or GDP eLearning training certificate for the subject(s) you followed.

In what language are the eLearnings available?

Each eLearning page has a section on eLearning language(s). Most of our eLearnings are available in Dutch or English, with subtitles.

What happens after I buy an eLearning?

You will receive an email containing a coupon. This coupon will contain the details to gain access to the eLearning course.

I did not get an email with a coupon

Emails may take up to five minutes to arrive. If you did not receive an email, contact us.

What's in an eLearning

Methodology

We explore the GMP / GDP theory, regulatory requirements and industry best practices.

  • eLearnings include interactive elements.
  • eLearnings often contain subtitles.
  • eLearnings are well-structured and easy to follow.
  • Every eLearning contains a written transcript.
  • Missed something? You can easily go back through the chapters.

eLearning platform

Our eLearning courses are hosted on our eLearning platform: Moodle. You can access our eLearning platform by navigating to: https://pcs-academy.site

In case the eLearning platform is unavailable at the time of purchase due to maintenance or server downtime you will be updated via email on restoration of the service.

Sharing and copyright

  • Selling or distributing these eLearning courses in their original or modified state is prohibited.
  • Sharing coupon (codes) is not allowed. Coupon codes may only be used by the persons/organizations as stated on the invoice.