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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 challenging parts of the QP’s daily work.


The Focus this year will be on interfaces and interaction with other functions.

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

Ulrich Kissel & Wolfgang Schmitt

Pre-Conference-Sessions: Please also see the Pre-Conference Sessions on 24 & 25 November 2020.

Programme

KEY NOTE: Quality Culture – Sue Mann
 
  • Why the focus on Quality Culture?
  • Why is it important for QPs?
  • Who creates culture and how?
  • The role of the QP within the company’s culture

The PIC/S GMP Inspection Reliance Initiative - Anne Hayes

  • How PIC/S and ICMRA aim to maximise inspection resources for GMP compliance of overseas facilities
  • The possibility of desk-top assessments of GMP compliance of overseas facilities
  • Benefits for both Industry and Regulatory Authorities

QP between Import and Export – the Impact from Annex 21 and Brexit - Tor Gråberg and Sipi Dhaliwal

  • Applicable and new Guidance
  • Current and future role of the QP in import and export activities
  • Necessary QP Supply Chain oversight
  • The QP/RP interface
  • Practical examples

The Role of the QP in the Company (A Code of Practice for QPs) - Richard M. Bonner, Georg Göstl and Ulrich Kissel

  • Various interfaces
  • Hierarchy and discretionary power
  • Organisation-chart and job description
  • How to foster decision making and autonomy
  • How to fulfil QP duties in a global environment

Challenges for IMP QPs - IMP Working Group

  • Relationship between Sponsor and IMP QPs
  • Brexit considerations

QP Scenarios – How serious could each Issue be? - Sue Mann and Gillian Renouf

  • Discuss real-life situations involving QPs
  • Explore the potential risks and impact
  • Make decisions on the product(s) involved

Liability and Delimitation of Responsibilities within a Company - Fabienne Diekmann

  • Delimitation of Responsibilities within
    • same site
    • different sites in the same country
    • different legal entities in different countries
  • Delimitation of responsibilities without contract
  • Allocation of responsibilities and liability to Head of QC, Head of Production and MAH
  • Amending employment contracts to include delimitation of responsibility

The QP - QPPV Interface - Cristina De Simoni Klitgaard and Karsten Lollike

  • Interfaces and delimitation of the responsibilities
  • Why co-operation is important (with examples)
  • How to foster co-operation
  • Benefits and limits

The new Annex 1 – what QPs should expect - Aidan Madden and Andreas Krassnigg

  • The most important changes
  • Influence on the QP certification process
  • Risk-based approach

Demystify Data Integrity: What’s really important for QPs - Wolfgang Schumacher and Rainer Gnibl

  • Data Governance and batch certification
  • Batch Record and Audit Trail Review
  • What are the critical data?

How to certify Drug-Device Combinations (DDCs, Combination Products) - Peer Schmidt

  • What the QP needs to know about the new Medical Devices regulations
  • Responsibilities of the QP when certifying DDCs
  • How to ensure that the medical device part meets the general EU safety and performance requirements
  • How to prove compliance with medical device regulations

Frequently asked Questions - David Cockburn

  • Benefi ts of the EQPA discussion forum
  • Answers to the most frequent questions
  • Interesting issues and possible solutions

Q&A Session

During the 2 days of the Forum, delegates can post their questions. The answers will be given by the expert speakers after the presentation or in dedicated sessions.

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