Foundation knowledge element of the UK Study Guide

Designed for experienced Quality Professionals and trainee Qualified Persons.
This course expands on the basics of quality management systems, providing experts with tools and techniques to ensure comprehensive oversight and efficient and effective implementation of the QMS

  • Key topics

    Outsourcing and vendor assurance programmes

    Embedding Quality Risk Management into the organisation

    Auditing and inspections to relevant legislation and guidelines

    Impact of planning and scheduling on quality and operational systems

    Quality Engineering including validation, calibration and planned preventative maintenance

  • Main Tutors

    Mike Halliday

    Tanya Agombar

    ___________________________

  • Included

    Workshops on implementing key quality systems, including:-

    - Design of PQS
    - Quality Governance
    - Managing change / project management
    - Training and competency

    Leadership for the QP – workshop developing the soft skills needed by the Quality Professional and Qualified Person

Learning outcomes

By the end of this module, you will have a comprehensive knowledge of the systems required to support the oversight and control of the manufacture, testing and distribution of a medicinal product, throughout its lifecycle by implementing robust a Pharmaceutical Quality System

  • Philosophy and principles of Quality Assurance, Quality Management across organisations
    Design of Quality systems appropriate to lifecycle stage and activities performed

  • Principles of Quality Risk Management, including hazard identification and risk mitigation, including where it can be utilised

  • Key Elements of Pharmaceutical Quality Systems, including:
    # Quality Management infrastructure
    # Production planning / scheduling and capacity planning, Vendor assurance including audits and technical agreement
    # Product Quality Reviews
    # Supply chain oversight
    # Design, control, validation of premises, equipment and utilities

  • Key interpersonal skill for the QP

In this portal

Your materials, assignments and assessments will all be provided through this learning portal

You will be notified by email when items are available for you to access...

  • 1 month before the course start date
    ~ You can access your course workbook
    ~ You will be able to download your Preparatory Assignment

  • Day before course start date
    ~ Downloads for workshops and exercises

  • End of each course day
    ~ Answers to exercises where appropriate

  • After course
    ~ Learning assessment
    ~ Course evaluation
    ~ Certificate

How to join us

You will each be sent an invite to join the course via Teams

Our experts will facilitate the group

Easily accessible for you - just follow the link you have been sent

Want to know more, find out about the discount bundles available, or book your training

Call us directly on
01622 477781
email us
[email protected]
or pop your email in the box below and we will get right back to you

Thank You