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Quality management in GDP

eLearning information

Updated Friday, July 5, 2024 at 8:44 AM

Reviews

Based on 104 participants

This eLearning explains the most important aspects for a quality system in GDP, including management review and the basics of quality risk management.

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 Intermediate level

Topics

GMP GDP EudraLex Volume IV Medicines Act Quality Assurance Qualification Quality Culture Packaging Distribution Data Integrity ALCOA Raw Data

Learning goals

  • Summarizing the requirements for Quality Management in a GDP environment,
  • Explain the expected content for Management Review,
  • Explain the basics of Quality Risk Management.

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

NOTE: Spoken text is in English. Dutch subtitles.  Wholesalers must maintain a quality system that outlines responsibilities, processes and principles of risk management in relation to the activities.

This course explains the most important aspects for a quality system in GDP, including management review and the basics of quality risk management.

Contents

  • Quality systems
    • What is quality?
    • Quality System (QMS)
    • What does the quality system guarantee?
  • Management Review and follow-up
    • Expected content
    • Process
    • KPIs
  • Quality risk management
    • What is Quality Risk Management?
    • How do you apply risk management?
  • Assignment, summary, exam and 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.