Qualified Person Forum
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.
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.
Pre-Conference-Sessions: Please also see the Pre-Conference Sessions on 28 November 2018.
Experiences made with the MRA and post-Brexit - Tor Gråberg
- Difficulties and how to overcome (inspections, GMP certifi cates, importation)
- What we have experienced
- Problems occurred and solutions found
GMP Update Session - David Cockburn, Rainer Gnibl and Tor Gråberg
- New Regulations and Guidance and their relevance for the QP
What the QP needs to know about the current Contamination Control Strategy - Walid El Azab
- Development of a risk-based assessment for contamination control and sterility assurance maintenance
- What the QP should be aware of before certifying products
- Where the involvement of the QP is needed
- Information flow
Real Time Release Testing and Certification by the QP: a next Generation Process or still Phantasm? - Line Lundsberg-Nielsen
- What the QP needs to know about Annex 17, ICH Q12 and Real Time Release concepts
- What is already possible – and what not
- Pre-requisites, chances and challenges
- What do authorities expect?
The PQR and its benefit for the QP - Klaus Eichmüller
- How the PQR could be used in an efficient way and not end in a graveyard of data
Working on Case Studies
1) Soft Skills for QPs
- How to analyse communication situations
- How to deescalate conflict situations
- How to show self-confidence in discussions with senior management?
Richard Bonner and Peter C. Zimmermann
2) Change Control and Certification for global Markets
- How to deal with change control challenges when regular approvals can take several months or years to cover all the relevant countries worldwide
- How to support decision making
Ulrich Kissel and Cristina De Simoni Klitgaard
3) QP Scenarios – How serious could each issue be?
- Discuss real-life situations involving QPs
- Explore the potential risks and impact
- Make decisions on the product(s) involved
Sue Mann and Gillian Renouf
4) Challenges for IMP QPs
- Sample and documentation retention, etc.
- Experience sharing, e.g. Brexit, new IMP GMP regulation
- Challenges for smaller companies
IMP Working Group
5) QP Oversight
- Practical aspects of keeping oversight on both external (third party) and internal (own site/ own company) QP-related processes
- QP responsibilities and delegation of tasks
Edel Ryan and Anke von Harpe
6) The QP in the Pharmaceutical Quality System
- Discuss how the QP can rely on a PQS and how such a system could be set up
- Assistance and support for the QP
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.