Qualified Person Forum

Full Day Pre-Conference Session

Specific Requirements for IMP QPs
9.00-18.00 h

Click on the image to open the programme as PDF

Facilitated by:
Susanne Ding | Barbara Glantschnig | Rebecca Haywood | Katrien Himpens | Marina Jarosch | Patryk Jegorow | Richard O’Sullivan | Martin Quigley | Mounir Rizovsky | Andreas Schwinn (other speakers invited)

• Legislation impacting IMP QPs
• IMP GMP inspection experiences
• How could AI & digital Tools support an IMP QP? (Panel Discussion)
• Product Specification File
• Automated release file preparation using robotics process automation
• IMP QP release models – contractor’s perspective
• The Enneagram Personality Model – why is it important for IMP QPs to understand yourself and understand others*
• How could AI & digital tools support an IMP QP? – panel discussion
• Interactive case studies
• Time for questions and answers

* all delegates will get a free copy of the book “More than a Number” by Martin Quigley

1/2 Day Pre-Conference Sessions

QP: Leadership with Impact
13.30-18.00 h

Facilitated by:
Arnoud Herremans | Ewa Rybak

• Practicing leadership without being in a senior management position
• QP vision and strategy needed
• Examples and interaction
  
  

What the QP needs to know about AI Implementation
13.00-18.00 h

Facilitated by:
Cheryl Chia | Monika Hupfauf | Markus Roemer

• What is AI – and what not?
• Possible implications of the new EU-GMP Annexes 11 and 22 and Chapter 4
• What questions to ask as a QP when implementing AI applications?
• How to use AI as supporting tool
• The role of AI and its acceptance in assessing documentation prior to batch certification
• How to rely on AI-generated output
• Legal challenges when relying on AI-generated output
• Liability of the QP when using AI