Objectives
Background
- Regulatory and legal requirements
- Analytical challenges
- Data Integrity and CSV
- Machine Learning
- Analytical method validation
- Investigation and prevention of OOS
- Case Studies
Target Group
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
Programme
Seminar Programme as PDF
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
Dr Karl-Heinz Bauer, Boehringer Ingelheim
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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Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org
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Seminar Programme as PDF
