QP pharmaceutical quality systems

3 Day/s

CPD Hours: 21

Classroom, Online, in-house, eLearning

RSC approved

The Qualified Person relies on the Pharmaceutical Quality System (PQS) to be able to fulfil their legal and operational responsibilities. This course provides a comprehensive overview of the requirements of the UK Study Guide. Scenarios and exercises are used to provide practical examples of how quality systems can be implemented in the real world.

This course now has an optional eLearning Knowledge Reinforcement Module available for delegates to purchase at £170.

RSC Logo Approved Training High Res (1)
A key course for all aspiring QPs, it will also be of benefit 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, providing the latest updates required for Continuing Professional Development.
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
    • QP Scenarios

    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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Bring this course in-house

Special offer

Helping your training budget go further

We offer a number of discounts and specials offers on our training courses including Group booking, NHS and Seasonal discounts.

Meet the tutors

Peter Deegan

Peter is an experienced Pharmaceutical QA professional, with over 30 years GMP, ISO 9001 Quality Systems, audit and training experience.

Rob Hughes

Rob Hughes has over 30 years in the pharmaceutical industry spanning various operational, project and senior strategic leadership positions in commercial manufacturing and development QA. Rob, a practising QP, has experience of the application of QA in many different areas including control laboratories, API, solids, creams and liquids manufacture, and third party audit and evaluation. Rob has many years experience of MHRA and FDA inspections.

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