GMP compliant planning and implementation of changes to API and finished medicinal products --- Expertise from gempex in a live online seminar and workshop --- ICH Q8, Q9, Q10, Q11, Q12 --- 29. and 30. April 2025
Supplier documentation according to GMP "out of the box" through standardization and specifics --- Presentation by gempex at the LOUNGES 2025 --- March 26, 2025, 17:00 to 17:30, Room 3
Recommendations, tips and practical experience with FDA investigations --- Technical lecture by FDA and audit expert from gempex at the LOUNGES 2025 --- Karlsruhe, 25.03.2025, 10 AM, Room 3
What needs to be done for an upcoming audit? --- How proceed before, during and after an audit? --- Basic knowledge and know-how --- Tips and practical advice --- Technical lecture from gempex
gempex presents the current service catalog: GMP Consulting & Execution and high-level consulting topics --- Inspection-Readiness, Remediation and Annex 1 Analyses --- gempex offers technical lectures on FDA, GMP Project Management, IT Validation and…
An important process step in the aseptic production of sterile pharmaceutical products --- New technical article from gempex --- Sterilization | Qualification | Validation | Filter integrity tests | Annex 1
gempex supports Sartorius Stedim Biotech GmbH --- The new Ksep® 50 Centrifuge System was, comprehensively tested and qualified, successfully launched on the market.
