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.