Pharmaceutical Quality Management System

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3 Day/s

CPD Hours: 21

classroom

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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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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