Conference: GMP Compliance Trends in Analytical Laboratories

26 November 2025

Background & Objectives

The aim of this conference is to address GMP compliance issues that are currently discussed as hot topics in analytical quality control laboratories and during GMP/FDA inspections.

Due to changing regulatory requirements, pharmaceutical quality control units are continuously facing new challenges. There are many regulatory requirements relevant for pharmaceutical quality control, both in the EU and in the US. Laboratory Managers and Analytical Scientists must be familiar with different GMP-related topics and must be aware of the latest updates and the current interpretation.

This conference therefore deals with the following topics:

  • Regulatory and legal requirements
  • Analytical challenges
  • Data Integrity and CSV
  • Analytical method validation
  • Analytical procedure transfers
  • Case studies

Target Audience

This conference will be of significant value to Laboratory managers, supervisors and analysts, Quality control managers, Heads of quality control, Qualified Persons (QPs), Analytical scientists, Senior laboratory staff, Responsible authorities.

This conference is also intended for employees in Quality Assurance and from contract laboratories. Furthermore, it is useful for service providers, such as contract research organisations and contract manufacturers.

Congress Registration

Moderation

Marcel Goverde, MGP Consulting

Programme

KEYNOTE on 25 November 2025: Artificial Intelligence in Pharmaceutical Industries
Dr Marcel Franke, Senior Scientist Predictive Formulation, Process Solutions/Upstream & Process Materials R&D Merck Life Science

Set-up of a QC Laboratory as Part of Greenfield Facility
Ivana Heckel, ten23 health

  • Integrating GMP requirements with safety and construction requirements
  • Challenges in collaboration with external partners
  • Process matrix to ensure integration and interfaces
  • Last check prior first GMP-analysis

Why every Factor matters in a Contamination Investigation
Jeanne Moldenhauer, Excellent Pharma Consulting

  • FDA/CDC investigation of a biologics plant showing significant differences from how a pharma company would conduct and root cause investigation
  • Investigation conducted and how it is different from company investigations
  • How to resolve/discuss these issues with regulators
  • Identify the important of SMEs in the investigation

Small CROs and Validation & Conduction of (Bio)analytical Methods
Dr Timo G. Kretzschmar, TiKrESolution

  • Consolidated Study Plans – All changes at a glance and free of contradictions?
  • Evaluation of measured data in spreadsheets
  • Data control mixed: manual and electronic
  • Audit-proof management of inventory lists and logbooks
  • Records: Paper versus electronic – what is the original?
  • Information search with artificial intelligence?

Universal Study Design for Instrument Changes in Pharmaceutical Release Analytics
Dr Anne Ries, Boehringer Ingelheim Pharma

  • Continuity – a challenge in pharmaceutical release analytics
  • Challenges posed by instrument updates or vendor switches
  • Performance differences between instruments, streamlining risk assessment and decision-making in regulated environments
  • Benchmark study that compares iCE3 and Maurice C instruments in icIEF analytics

Auditing Audit Trails - QA vs QC Perspective
Martina Gjorgjevska and Apostol Todorovski, The FORCE CT

  • What is the role of audit trails in GMP
  • QA vs QC perspectives on audit trails - real-life examples
  • What should an audit trail capture?
  • Auditing audit trails - a risk-based approach
  • Common pitfalls and how to avoid them

Audit Trail Requirements for Digitalised GMP Laboratories
Dr Bob McDowall and Mahboubeh Lotfinia

  • Key regulatory requirements and ALCOA++ criteria for audit trails
  • Application architecture for audit trail(s) from data acquisition to archive
  • A single audit trail review SOP?
  • Technical control requirements for audit trails

Evaluation of Stability Data: Extrapolation of Shelf-Life by Statistical Analysis
Dr Joachim Ermer, Ermer Quality Consulting/Member of the AQCG Board

  • ICH Q1E: Conditions for extrapolation (decision tree)
  • General statistical approach (95% confidence intervals)
  • Statistical analysis: individual batches or pooling?
  • Impact of manufacturing and analytical variability
  • Draft ICH Q1 guideline: Adjustments & changes (mixed effects model, enhanced stability modelling)

Improving Analytical Procedure Transfers in the Pharmaceutical Industry
Ulla Bondegaard, Novo Nordisk

  • Method transfer strategy focusing on a method-performance based approach and hyper care
  • Effective planning and execution of transfers to multiple sites
  • Best practices for transferring procedures to internal teams and CMOs
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