Qualified Person Forum
The Main Conference - 12-13 October 2023
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 Forum is designed for all Qualifi ed 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 Qualifi ed Persons.
Click on the image to download the Qualified Person Forum 2023 programme as PDF.
Please see the registration options to register for the QP Forum 2023.
Artificial Intelligence and Digitalisation in Pharma
Dr Jörg Stüben
- How will Artificial Intelligence (AI) infl uence GMP?
- Benefi ts and limits
- Possible consequences for the QP
- What else does the digital future bring?
General GMP Update – News for the QP besides the big Topics
- Current legal developments
- EMA news
- Trusted Partners news
Parametric Release according Annex 17
- Current GMP requirements and developments
The Future of personalised Medicine and the Role of the QP
- How personalised medicine is transforming healthcare
- Expectations, chances and limits
- The role of the QP
What the QP needs to know about Blockchain in Pharma
- What exactly is blockchain
- Where is it used
- What it means for GMP-relevant activities
Reverse Risk Management and the Use for the QP
- What it is
- How to use it
- Benefi ts for the QP
Contamination Control Strategy (CCS) Use for the QP
Walid El Azab
- The Importance of CCS for the QP to confirm reliance with the Quality System
- Implications of a robust CCS evaluation
- How to minimise the grey area in QP decision-making
- Shaping QP discretion
Parallel Interactive Sessions
Delegates participating on-site in Vienna will be able to attend three of these six parallel sessions. Please choose the ones you like to attend when you register for the Forum.
Delegates participating live online will be able to join the sessions marked with
1) Import/ Export Challenges for the QP
Rainer Gnibl and Ulrich Kissel
- What the QP needs to know
- Annex 21 in practice
- What are the QP responsibilities and where do they end?
2) Oversight of the Tasks that QPs can delegate
Cheryl Chia and Frank Seibel
- What are the tasks, a QP is responsible for?
- How can QPs assure themselves that these tasks are completed as intended and expected?
- How can QPs rely on the processes?
- Exercise: examine your organisation’s PQS if the processes provide sufficient assurance to QPs
3) QP Scenarios – How serious could they 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
4) Challenges for IMP QPs
IMP Working Group
- Product Specification File
- Legal framework
- (contractual arrangements, technical agreements)
- Quarantine shipments
5) What the QP needs to know about pharmaceutical Contracts
Carsten Coors and Monika Hupfauf
- What does a QP need to know?
- EU regulations vs. non-EU regulations – what counts?
- How to keep the overview
- How to integrate QP responsibilities and defi ne the respective adequate remedies in the contract
6) QP’s Leadership Role in strategic Management: Soft Skills for Quality Professionals
Afshin Hosseiny and Ramzan Tabasum
- How to say “no” when it is needed