Regulatory developments from an industry perspective
What are inspectors looking for?
How to prepare ahead of time
Practical insights in inspection preparation
AI Strategy & AI Governance – The Big Picture
What do organizations need to consider when approaching AI in GxP
How does AI strategy interconnect within a typical corporate strategy layout
What governance functions are relevant and how do they integrate
How can enabling elements like data, Quality, and technology be activated
GenAI Platform: A Technical and Compliant Approach for Complaint GenAI Usage in a GxP-Regulated Environment
Platform mindset: Embracing a platform-oriented approach to leverage GenAI capabilities effectively.
Democratization of Technology: Ensuring easy access to GenAI tools across the enter-prise, empowering end-users to innovate responsibly.
Quality Risk Management: Implementing a comprehensive quality risk management framework to evaluate and mitigate potential quality impacts associated with GenAI usage.
AI-Based Assistance Software to Increase Production Efficiency in a GMP-Regulated Environment
Maintenance Challenges
How knowledge databases work
Framework Conditions for the Use of the AI-Based Assistant
Quality Control of Knowledge Entries
Benefits, Impact, and Outlook
Digitalization/Automation as the Basis for the Efficient Use of AI in QA and QC
Basics for QC & QA on IT framework - digitalization - automation - use of AI
Generation of raw data and data systems
Real-life automation examples and AI examples from QA & QC
AI in Maintenance – Between Expectation and Reality
Critical Reflection on AI in Maintenance
Expectations and roadblocks
Limits of data driven Models
Pragmatic alternatives
Practical experience at CSL
AI in the Pharmaceutical Industry: Regulations, Quality Assurance and Practice
Regulatory requirements (EU AI Act, Annex 11, 22, Chapter 4, Part 11)
AI governance: managing risks associated with non-GxP systems in a GxP environment
Validation: CSV as a holistic approach for compliant AI
Human-machine interaction: Human-in-the-loop vs. human-centric concept
Practical examples: Benefits of AI in quality assurance / Thoughts on the potential and risks of AI for patient care
Outlook: The future role of AI agents
AI and Data Integrity: Limitations (Guardrails) and Opportunities in a Regulated Environment
Why data integrity is critical in the GMP environment – an overview of regulatory requirements
Challenges posed by AI – risks to data integrity in generative and agentic systems
Agentic AI in a regulated environment – the limits and potential of AI
(Guardrails as a solution)
Outlook – future developments/trends
Beyond Hype and Shadow AI: Building Trusted, Compliant AI in GxP
Deep domain and process knowledge to correctly frame AI use cases
Reliable data quality and availability as the bedrock of compliance
Robust governance frameworks (e.g., the 4G model: Guard, Govern, Guide, Gate) to align with GxP, ISO, GDPR, and FDA expectations
Practical use cases, such as applying AI to product risk management, showing how copilots can accelerate risk assessments while maintaining audit-readiness
Accommodation CONCEPT HEIDELBERG has reserved a limited number of rooms in the conference hotel. You will receive a room reservation form/POG when you have registered for the course. Reservation should be made directly with the hotel. Early reservation is recommended.
Conference language The official conference language will be English.
Get Together
On the evening of 07 October, the participants are cordially invited to a dinner. This event is an excellent opportunity to share your experiences with colleagues from other companies in a relaxed atmosphere.
Fees (per delegate, plus VAT) ECA Members 3,080 EUR APIC Members 2,880 EUR Non-ECA Members 2,190 EUR EU GMP Inspectorates 1,340 EUR The conference fee is payable in advance after receipt of invoice and includes conference documentation, lunch on all conference days, social event including dinner on 07 October, and all refreshments. VAT is reclaimable.
Presentations/Certificate The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on site and that there will not be any opportunity to print the presentations on site.
Testimonials
