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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.

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What’s included

  • Complete in 45–60 minutes, at your desk
  • Certificate on completion, keep for your audit trail
  • Full transcript and subtitles included
  • 365 days of access from purchase
  • Quiz-validated learning, proof you understood the material

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 take this eLearning

  • Built by the same PCS consultants who advise real pharma firms, not generic e-learning vendors
  • A certificate you can show your QP, QA manager or auditor
  • Straightforward GMP / GDP content, no fluff, no filler
  • Closes with a quiz so you can prove you understood the material

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?

You have 365 days from purchase to complete the course. Work at your own pace, no fixed deadlines, no live sessions to attend.

Do I get a certificate upon completing the eLearning?

Yes. Once you pass the quiz you receive a PCS Academy training certificate for the GMP or GDP topic you covered, suitable for your HR file and audit trail.

In what language are the eLearnings available?

Most courses are available in Dutch and English with subtitles. Check the course detail for the specific languages offered.

What happens after I buy an eLearning?

You receive an email with a coupon and instructions to access the course on our learning platform. For invoice or bank transfer payments, the coupon is sent once payment is received.

I did not get an email with a coupon

First check that the payment has cleared. Coupons are issued manually on working days, if nothing arrives within a few hours, get in touch and we will sort it out.

What's in an eLearning?

How the course is built

Every course is written by the same PCS consultants who advise pharma firms day-to-day. Theory is grounded in current GMP / GDP requirements and what actually works on the floor.

  • Interactive elements keep you engaged, no 60-minute talking heads.
  • Subtitles available on most courses.
  • Structured in short chapters you can pause and resume.
  • Full written transcript included for reference and audit purposes.
  • Jump back to any chapter at any time during your 365 days of access.

Learning platform

Courses are delivered through our Moodle-based platform at https://pcs-academy.site. Log in from any browser, on any device, your progress is saved between sessions.

If the platform is briefly unavailable for maintenance we will email you when it is back up.

Sharing and copyright

  • Reselling or redistributing these courses, modified or not, is not permitted.
  • Coupon codes are tied to the person or organisation on the invoice and cannot be shared.