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
- Machine Learning
- Analytical method validation
- Investigation and prevention of OOS
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.
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.
Programme
Seminar Programme as PDF
Set-up of a QC Laboratory as Part of Greenfield Facility
Ivana Heckel, ten23 health
Why every Factor matters in a Contamination Investigation
Jeanne Moldenhauer, Excellent Pharma Consulting
Small CROs and Validation & Conduction of (Bio)analytical Methods
Dr Timo G. Kretzschmar, TiKrESolution
Universal Study Design for Instrument Changes in Pharmaceutical Release Analytics
Dr Anne Ries, Boehringer Ingelheim Pharma
Auditing Audit Trails - QA vs QC Perspective
Martina Gjorgjevska and Apostol Todorovski, The FORCE CT
Audit Trail Requirements for Digitalised GMP Laboratories
Dr Bob McDowall and Mahboubeh Lotfinia
Evaluation of Stability Data: Extrapolation of Shelf-Life by Statistical Analysis
Dr Joachim Ermer, Ermer Quality Consulting/Member of the AQCG Board
Improving Analytical Procedure Transfers in the Pharmaceutical Industry
Ulla Bondegaard, Novo Nordisk
| Regular Fee*: | € 590,- |
| EU/GMP Inspectorates*: | € 345,- |
(All prices excl. VAT). Important notes on sales tax.
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Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org
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Seminar Programme as PDF
