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Take this Course  1hr 10min

Good Distribution Practice – Change Control

A Change Control within a Quality Management System (QMS) is a formal process used to ensure that changes to a product or system are introduced in a controlled and coordinated manner. It reduces the possibility that unnecessary changes will be introduced to a system without forethought, thereby introducing faults into the system or undoing changes previously made.

In this course you will learn the importance of a robust Change Control procedure, in line with the EU GDP Guidelines 2013/ C 343/01. Above all, you will know how to implement and maintain quality and compliance with GDP within your company.

See our Course Content list below for more information on the modules included in this course. There is also an informative Change Control Blog.

The learning objectives of our Good Distribution Practice – Change Control course are:

  • To understand what Change Control is and why it is required.
  • To recognise the potential implications and patient safety impact of non-compliance.
  • The importance of pre-implementation approval and effectiveness checks.


You will also learn about:

 

  • Change Control Flow Charts.
  • Quality Assurance Closure – Post-implementation

 Click the button below for supporting documentation about GDP if you wish to continue your learning journey.

Supporting Documents

Please note that you can revisit these useful pages through your account.

Experiencing problems? Please click the blue help icon for details on how to contact us.

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What's your experience? We'd love to know!
Rajesh Matthew
Posted 3 years ago
Control Change

Very useful topic

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