PQS - Product Quality Review (eLearning)

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30.00 Minutes

CPD Hours: 0

e-Learning

This course forms part of our 12 module Pharmaceutical Quality System eLearning course. This is a highly interactive eLearning course provides a comprehensive introduction to the topic. The course has a knowledge assessment to check learning has been retained.

The course is relevant to anyone working in both quality and operational roles. In particular, this course is of direct relevance for those working in quality compliance or quality system roles.

This course includes the following topics :


  • The role of the Marketing Authorisation Holder in Product Quality Review (PQR)/ Annual Product Review (APR) preparation and approval
  • The key elements of the PQR/ APR for products and active substances
  • The actions to be taken on conclusion of the PQR/APR

    By the end of this module you will be able to:


    • Describe the role of the Marketing Authorisation Holder in Product Quality Review (PQR)/ Annual Product Review (APR) preparation and approval
    • Describe the key elements of the PQR/ APR for products and active substances
    • Describe the actions to be taken on conclusion of the PQR/APR

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eLearning - Pharmaceutical quality system

Gain a comprehensive understanding of the key elements required for a successful Pharmaceutical Quality System (PQS) implementation and ongoing maintenance of quality standards, based on ICH Q10, EU / UK GMP and FDA guidelines