Conference: GMP Compliance Trends in Analytical Laboratories

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.

 

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Moderation

Dr Christopher Burgess, Chairman ECA AQCG

Tuesday, 26 November 2024

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.

Getting inspected by the FDA for the first Time - our Experience
Dr Katharina Elisabeth Scheidt, Microcoat Biotechnologie

• Important points for preparation
• Inspection readiness
• Expectations versus facts
• Lessions learned

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

• Overview about analytical class of PFAS
• Insight general existing regulation
• Analytical complexity and possibilities
• Occurrence of PFAS in relevant resource materials
• First view on findings in pharmaceutical products

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

• Introduction: Current state of existing commercial ML solutions in the pharmaceutical QC
• Machine Learning Terms and Definitions
• Current regulations such as FDA's discussion paper on AI/ML, EMAs reflection paper and Good Machine Learning Practice
• Validation approaches: Data split, model lifecycle, monitoring and retraining
• Case studies for Risk Management with ML subsystems: CFU counting, Spectroscopy, more to come

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

• Introduction to Analytical Platforms
• Standard vs. Accelerated Development
• Method Performance Expectations
• Fit-to-Platform Assessment
• Design Space and Robustness
• Total Analytical Error (TAE)
• Prior Knowledge and Qualifications
• Regulatory Considerations<

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

• Method Development: Avoiding Future Pitfalls
• Solid Risk analysis and study plan
• System Suitability: A Risk-Based Approach
• Investigations/Deviations during Validation Projects
• Data Integrity during Validation Projects
• Comprehensive Audit Trail Review

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

• The role of “Data”, electronic, and computerised systems in the application of ICH M10 Guideline
• Dependence of data from platform/technology – important issue
• The integrity and validity of the results within the focus – some examples
• Data relationship of the validation parameters (like LLOQ, ULOQ, accuracy, precision etc.)
• The role of e.g. LIMS as documentation tool
• Data integrity and eCTD (regarding submission)