Qualified Person Forum

The Main Conference - 01-02 December 2022

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.

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

Programme

QP Forum Programme

Click on the image to download the Qualified Person Forum 2022 programme as PDF.

Registration

Please see the registration options to register for the QP Forum 2022.

Agenda

General GMP Update – News for the QP besides the big Topics
Andreas Krassnigg

  • Developments in EU legislation
  • PIC/S Annex 16 “Certification by the Authorised Person and Batch Release”

Annex 1: Consequences for the QP
Robert Schwarz

  • What’s important for the QP
  • What manufacturers of non-sterile medicinal products should know and take into account

QPs in a Time of electronic Data
Cheryl Chia and Tor Gråberg

  • Definitions of the different types of data
  • Relationships between the different types of data
  • Examples showing the linkages in practical situations
  • How this translates to QP decisions and fulfilling QP responsibilities – not all data is equal

Examples for inappropriate Risk Management – and how it could be done better
Alexandra Bauloye and Franz Schönfeld

The term “quality risk management” is used throughout Annex 16. But how could the QP benefit from this tool? In this session you will get some practical advice!

MAH, MIA, Senior Management: who’s behind it?
Sandra Moricz

  • Roles and responsibilities
  • Interfaces with the QP

The QP’s Responsibilities in daily Practice
Frank Seibel

  • QP, Head of Production, Head of Quality Control: how do these functions work together
  • How can duplication of work be avoided
  • How can responsibilities be delimited, e.g. also and especially at the interfaces: sample collection and storage, warehousing, batch record review, deviations, changes etc.

Import and Export – what the QP needs to know
David Cockburn, Rainer Gnibl and Ulrich Kissel

  • What the QP needs to know: basic requirements
  • Consequences of Annex 21 and Brexit

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

Current Challenges in the Supply Chain (and possible solutions)
Maria Söderblom

  • The reasons for drug shortages / shortages of APIs, excipients, equipment and materials
  • Possible solutions for industry and the QP

Case Studies: Business Continuity
Tilman Rock

  • How to deal with Corporate Risks
    • Energy crisis
    • Staff shortages
    • Pandemic
  • Role of the company and senior management
  • Role of the QP

Panel Discussion on the Downstream Part of the Supply Chain:  Where do GMP and the QP responsibility really end?
Cheryl Chia, David Cockburn, Afshin Hosseiny and Ulrich Kissel

Q&A Session

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

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