Pharmaceutical Quality Management System

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3 Day/s

CPD Hours: 21

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Provides 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 course provides a comprehensive and detailed guide to a Pharmaceutical Quality System, based on ICH Q10, EU / UK GMP and FDA guidelines.


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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 includes the following topics and reinforced using group exercises:


  • Day 1
    • Philosophy of Quality Management
    • Introduction to PQS
    • Issue Management
    • Complaints and recall
    • Training
  • Day 2
    • Documentation
    • Validation / Qualification
    • Audits & self-inspection
    • Outsourcing
    • Change Management
  • Day 3
    • Product Quality Reviews
    • Management Review
    • Influencing / leadership skills
    • Soft skills
    • Quality Risk Management
    • Future of Quality Management

    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
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Pharmaceutical Quality Systems (eLearning)

Covers 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