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QUALIFIED PERSON FORUM 2021

02-03 DECEMBER 2021

Objective

The Qualified Person Forum is generally 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

Pre-Conference-Sessions: Please also see the Pre-Conference Sessions on 01 December 2021.

Programme

KEY NOTE: COVID-19 - the Challenge of making new Treatments available during Pandemic and dealing
with missing Guidance
– Martinus de Jonge

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

Annex 21: Consequences for the QP - Rainer Gnibl and Ulrich Kissel

  • Responsibility of the importing company and the QP
  • Batch testing and certification
  • Contractual regulations

IMP QP at the Interface to commercial QPs - IMP Working Group, Edel Schortt

  • Hand-over from clinical to commercial

Creating or Improving QP Oversight into the Supply Chain - Cheryl Chia and Afshin Hosseiny

  • How to understand Supply Chain Diagrams (SCD)
  • What the QP really needs and why
  • How to improve and implement SCDs

Brexit Implications for the QP - David Cockburn and Ulrich Kissel

  • UK and EU Point of View
  • Impact on the roles and responsibilities of the QP

Case Study: How to deal with severe Inspection Findings (“How not to lose your License”) - Gábor Mihályi

  • What had led to severe inspection findings
  • What happened after receiving the inspection report
  • What to do and who to involve with the inspection remediation?
  • How was it affecting other sites?

Quality Risk Register/ Business Continuity Plan - Alexandra Bauloye and Aidan Madden

  • What is it, how to develop it and which type of risks to include
  • What to show to authorities?
  • The way to business continuity – what can the QP learn from this overall process?
  • Involvement of the QP (before things go wrong)

What to know about PDEs and Threshold Levels for Impurities - Andreas Flückiger

  • What to know about impurities and other chemical contaminants
  • How to deal with diff erent contaminants from a toxicological point of view
  • What do the limits mean? How are they set and how are they to be understood?
  • Why to know your toxicologist (Why the relationship with the toxicologist is important)

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

EDQM’s approach on Real Time Remote Inspections - Thomas Hecker

  • Results and impressions from EDQM’s real time remote inspection pilot project
  • Advantages/disadvantages of the approach and it’s future use within EDQM’s GMP assessment system of API manufacturers

Discussion: Can Distant Assessments replace on-site Audits after the Pandemic? - Rainer Gnibl and Tor Gråberg

  • GMP Inspectorate and Industry Point of View

Q&A Session

During the 2 days of the Forum, delegates can post their questions in writing. The answers will be given by the expert speakers after their presentation or in dedicated Q&A sessions. If not answered during the conference, open Q&As will be published in the members’ area of the EQPA website.

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