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Qualified Person Forum

Objective

This Conference is designed by QPs for QPs as an international Expert Forum with focus on sharing information and experience and on discussing the critical areas of the QP’s daily work.

Target Group

The Forum is designed for all Qualified Persons and aspiring Qualified Persons. It also addresses upper management functions and authority representatives who want to be informed about the latest development regarding the duties and responsibilities of Qualified Persons.

Forum Moderator

Aidan Madden

Pre-Conference-Sessions: Please also see the Pre-Conference Sessions on 28 November 2018.

Programme

KEY NOTE: Being a QP - why do I have the best Job in the World? – Aidan Madden
  • Why I was choosing to become a QP
  • What is behind being a QP
  • Enjoy your Job!

Update on International Developments and their possible Impact on GMP and Manufacturers - David Cockburn

  • Brexit
  • MRA with FDA and other MRAs

GMP Update Session – Rainer Gnibl and Tor Graberg

  • New Regulations and Guidance and their relevance for the QP
    • Annex 1
    • ICH Q12
    • others

How to report serious GMP Deviations and Fraud - Martine Powell

  • EMA Policy Guide 0072 on “Handling of information from external sourcing disclosing alleged improprieties”
  • Deviations/fraud at subcontractors and/or raw material suppliers
  • Deviation/fraud at own premises
  • What are the obligations of the QP in serious cases
Data Integrity: Examples why Data Governance is important for QPs – Rainer Gnibl
  • Examples why Data Governance is important for QPs
  • What to look for
Quality Culture is what allows me (and the QP) to sleep well at Night – Guy Villax
  • Compliance versus Quality
  • Why does the tone need to be set at the top
  • What is evidence of a quality culture
  • When things go wrong,: what matters is how you deal with it

Parallel Sessions

Working on Case Studies

You will be able to attend three of these parallel sessions. Please choose the ones you'd like to attend when you register for the Forum. 

1) How to deal with post-marketing Issues - Richard Bonner, Georg Göstl and Sabine Sereinig

  • There is more than just Complaint and Recall Handling
  • How to react as a QP?
  • To notify or not?

2) KPIs and Quality Metrics for QPs - Ulrich Kissel and Cristina De Simoni Klitgaard

  • Meaningful KPIs for QPs and what to learn from them
  • How KPIs can create wrong behaviour
  • Involvement of the QP
  • Examples for good KPIs for QPs

3) QP Scenarios – How serious could they be? - Sue Mann and Gillian Renouf 

  • Make decisions based on real-life situations

4) Changes at the GMP-GCP Interface - IMP Working Group
Continuing to shed light on grey zones and sharing experiences

5) Supply Chain Diagram and Overview - Afshin Hosseiny and Bernd Renger

  • How to implement chapter 1.7.2 of Annex 16
  • Why Supply Chain overview is more than just a diagram
  • The GDP Interface

6) CMO Oversight – the QP Perspective - Paul Sexton and Ann McGee

  • What does Quality Oversight mean for a QP
  • How to deal with the various quality and documentation systems at different CMOs
  • Management of significant cGMP compliance problems (is there a “warning system”?)
  • Information and communication
  • Maintenance and monitoring

Q&A Session

During the 2 days of the Forum, delegates can post their questions. The answers will be given by the expert speakers in a dedicated session and/ or published in the members’ area of the EQPA Website.