Introductory GMP Quality Oversight Course for European Drug Products

Learn about the principles of Good Manufacturing Practice (GMP), the legal requirements, and best practices for effective and efficient Quality Oversight on external manufacturing. Consists of 3 interactive modules containing 7 chapters.

 99.00

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Region of Regulation

Regulation

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Introductory GMP Quality Oversight Course for European Drug Products

 99.00

Learn about the principles of Good Manufacturing Practice (GMP), the legal requirements, and best practices for effective and efficient Quality Oversight on external manufacturing. Consists of 3 interactive modules containing 7 chapters.

Category: Tag:

LEARNING OBJECTIVES

  • Awareness that GMP is applicable to all roles involved in the manufacturing of (investigational) drug products, including external manufacturer / CMO and other vendors
  • Setting up and managing compliance with quality standards for both the internal organization as the vendors
  • Complying to GMP and quality standards makes processes efficient, accurate, and reliable.
  • Ensure the safety of the subjects and patients by making sure the (investigational) drugs are consistently produced and controlled according to (GMP) quality standards by vendors
  • Understand how to perform quality oversight on their production and control.
  • Understand oversight elements such as vendor selection, quality visits, and clear communication processes

 

DESCRIPTION

The Introductory GMP Quality Oversight Course for European Drug Products is the self-paced online training solution for GMP quality professionals who are responsible for quality oversight of pharmaceutical contract manufacturing and need to be aware of the GMP requirements as laid down in ICH Q9, Q10 and EU-GMP Guide including the Annexes. It ensures awareness and understanding how a quality system is set up in an outsourced model.

This training is applicable for the Quality department, the QMS team, management of pharmaceutical and biotech companies, drug product development leaders, clinical study supply leaders, CMC leaders, and all others involved in quality oversight. It allows you to retain quality oversight in compliance with the International and EU GMP legislations and is the best choice for those who like the flexibility of online learning at their own pace and time.

• GMP certificate
• Practice-based and interactive learning
• Easy accessible via smartphone, tablet, or desktop
• Self-paced and modular

This course has been developed in collaboration with Quality Oversight experts and translates the GMP framework to practice. It gives you the tools and examples to directly implement the knowledge in your daily practice.

Role-based GMP requirements and Quality Oversight elements are explained in 3 modules, based on a logical order of steps to take. This course will support pharmaceutical and biotech companies in the setup and execution of Quality oversight of contract manufacturing.

After you have completed all the learning elements of the e-learning course, you will directly receive the GMP Certificate online. All training courses include one-year of access to online training. With our continuous learning model, we will keep you up-to-date with changing regulations and guidelines.

Enroll now to get started with the online learning modules on your smartphone, tablet, or desktop computer.

 

COURSE CONTENTS

[toggles title="Module:  Introduction"]
You'll learn the following in this module:

  • Introduction
  • Quality Management
  • Documentation

[/toggles]

[toggles title="Module:  Quality Oversight"]
You'll learn the following in this module:

  • Tech Transfer and Validation
  • Oversight on Production and Quality Control

[/toggles]

[toggles title="Module:  Review, Final Product, Recalls"]
You'll learn the following in this module:

  • Distribution and Recalls
  • Product Lifecycle Management

[/toggles]

Additional information

Job Role

, , , ,

Language

Level

Phase of Study

Region of Regulation

Regulation

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Learn anytime, anywhere

Learn at your own pace on your smartphone, tablet or desktop. You will have one year of access to the training and resources so you can look up information even after you’ve completed the course.

Learn Continiously

Continuous Learning can both improve clinical research quality and ensure a motivated research team. You’ll benefit from better knowledge retention and reduced risks.  We When a regulatory update is announced, we update the training modules and notify you, so that you can take the updated module and earn a new GCP certificate.

Earn your gcp certificate

With our courses, you can earn and maintain your vital industry-recognized certificate. In your GCP Passport, you can now see exactly which version of a training module you were most recently trained on. This documentation in combination with the changelog will inform auditors, managers, and inspectors of the associate’s compliance with current regulations.

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