Pharmaceutical quality system (eLearning)

5.00 Hour/s

CPD Hours: 4

e-Learning

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. This highly interactive eLearning course provides a comprehensive and detailed guide to a Pharmaceutical Quality System, based on ICH Q10, EU / UK GMP and FDA guidelines, over 12 highly interactive, impactful modules. Each module has a knowledge assessment to check learning has been retained.


If you wish to try before you buy, book free trial version.

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.
The course takes around five hours to complete and the modules/timings, are as follows:


  • Introduction to PQS [45 minutes]
  • Quality Risk Management [25 minutes]
  • Validation and Qualification [30 minutes]
  • Supplier Management [15 minutes]
  • People and Training [20 minutes]
  • Documentation [20 minutes]
  • Deviation and CAPA Management [20 minutes]
  • Change Management and Control [20 minutes]
  • Product Quality Review [30 minutes]
  • Management Review [20 minutes]
  • Audits and Self Inspections [15 minutes]
  • Complaints Quality Defects and Product Recalls [30 minutes]

    By the end of the course you will know and understand:


    • The key role the PQS plays in ensuring quality and compliance
    • The key elements of a PQS
    • The role of PQS
    • Monitoring and oversight of the PQS
    • The current regulatory expectations for PQS and how these can be achieved
    • The interpersonal skills associated with maintaining a robust PQS infrastructure
£ 350

ex VAT

Volume Discounts

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01 to 09 delegates £350 + Vat per delegate 10 to 19 delegates £300 + Vat per delegate 20 to 49 delegates £250 + Vat a delegate. For volume pricing over 50 delegates, please email training@rssl.com