Conference: GMP Compliance Trends in Analytical Laboratories

26/27 November 2024

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..

Background

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
  • Machine Learning
  • Analytical method validation
  • Investigation and prevention of OOS
  • 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.


Registration

 

Programme

Key Note on 26 November: The Promise and Challenges of In Vitro and In Silico Models in Drug Development
Dr Julia Schüler, Charles River Laboratories
The presentation will highlight important developments in the drug development technology landscape influenced by the concept of 3R and the evolving legal landscape. General characteristics of the different applications, their translational relevance as well as adoption drivers will be discussed. Case studies from oncology drug development will help to elucidate these trends and their impact on future processes.

Key Note on 27 November: Trends & Challenges for the Development & Testing of Biotech Drug Products
Prof. Dr. Hanns-Christian Mahler, Chief Enablement Officer (CEO), ten23 health

Recent Trend of GMP Observation in Analytical Laboratories
Subhrangshu Chaudhury, Centaur Pharmaceuticals

PFAS in Pharmaceutical Products – a View on Findings and Potential Relevance
Stephan Lebertz, SGS Institut Fresenius

Machine Learning in the GMP Lab - Regulation, Validation and Case Studies
Dr Ulrich Köllisch, GxP-CC

Optimizing Precision: Strategies for Validating Analytical Platforms
Dr Mohamad Toutounji, Molgenium

Analytical Method Validation in Pharmaceutical Products according to ICH Q2 and in Biological Matrices according to ICH M10 using HPCL-UV, HPLC-MS and ELISA
Dr Reingard Raml, JOANNEUM RESEARCH Forschungsgesellschaft

Data Integrity and CSV of the Computerised Systems used to Manage GxP data – a Necessary Precondition for a Valid (Bio)Analytical Method?
Dr Timo G. Kretzschmar, TiKrESolution

Digitalisation and Automation of Validation Activities
Christophe Girardey, wega Informatik

Unraveling Out-of-Trend Stability Results: A Case Study in Identification and Investigation
Sanja Despotovska, Alkaloid

Concepts to Prevent Lab Errors & Unconfirmed OOS in QC Laboratories
Christophe Girardey, wega Informatik

Health Authority Challenges to the Well Established Dissolution Specification of a Mature Drug Product - a Case Study
Dr Lukas Sonnenschein, Merck Healthcare

Hard Facts about Softgels: Analytical Challenges and Regulatory Gaps
Dr Ana Petkovska, Patheon by Thermo Fisher Scientific

Applying Life Cycle and Validation Principles to the Customized Amplex UltraRed Assay
Dr Alexandra Heussner, Vetter Pharma

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