QP Workshop

1 Day/s

CPD Hours: 6


Our quarterly face to face QP workshops are designed to help our trainee Qualified Persons develop the skills and knowledge they need to become certified. From assessing the latest recalls and looking at real life scenarios, to considering new product introductions and supply chain impact, these sessions will support those who are writing their QP application form or preparing for their VIVA.

Highly interactive, each workshop will dive into a range of planned topic areas with both small group and wider discussions initiated to help encourage creative thinking and retain learning. Each delegate will be equipped with the skills to assess potential and actual changes within the framework of 2001/83 or 2001/82, developing their interpersonal skills through a series of role play exercises. In addition, each delegate will have the opportunity to help shape the agenda for future workshops!

These sessions are designed to provide learning reinforcement for delegates who have joined our QP Training and VIVA Support Programme – namely QPs and trainee QPs.

We also welcome other trainee QPs regardless of their stage, as well as those newly qualified looking to update their knowledge and build their network.

These workshops are also relevant for those that need to advance their GMP, GDP and production knowledge, in addition to regulatory and quality professionals impacted by the topics under discussion.

March 2024

This upcoming session will cover:

  • Training for QPs new to the role / business – what do you need to know and when?
    • First 90 days in a role
    • Personal versus delegated duties
  • Nitrosamines – what is needed, what was learnt?
  • The Windsor Framework – the impact on QPs
  • China – the changing regulatory landscape
  • Auditing
    • What is a QPs role in auditing?
    • What impact do poor audit outcomes have on the patient and product?
  • Post Inspection Letters (PIL) – the impact on QPs and how to manage afterwards
  • Do you know what CoUP is?
  • Quality culture – what is it and how to get it

The programme for other upcoming sessions is still being worked on and will be announced shortly.

    By attending the quarterly workshops you will:

    • Become proficient at working through real life scenarios facing QPs, from new product introductions to deviations to supply chain impact
    • Become confident in performing risk assessments in a variety of situations
    • Understand when to challenge and how to handle being challenge
    • Improve your rational thinking
    • Gain confidence answering QP VIVA questions using a structured approach
    • Develop your interpersonal skills
    • Learn how to work effectively in a group situation
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Meet the tutors

Rebecca Rutter

Rebecca is a Qualified Person and Responsible Person (Eligible to act as a Qualified Person under the permanent provisions) with expertise with Biotechnology products and provision of support for Advanced Therapy Medicinal Products (ATMP). She has held Director positions at some of the most prestigious pharmaceutical companies where she has specialised in setting up and running greenfield manufacturing facilities, systems, processes, supply chain and achieving strategic business milestones.

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