Live online conference on 16 and 17 November with Ralf Gengenbach. Presentation of the revised ECA Guide 2.0, which now includes feedback from regulatory authorities, the pharmaceutical industry and suppliers. Time-saving qualification and validation…
November 15, 2021 | 3:00 p.m. | Düsseldorf | Hall 14, Booth 14F22
Which medical device regulations do market authorization holder of integral combination products have to take into account in order to place their product on the European market? Are there any…
November 30, 2021 | 10-11 a.m. | Medical Devices: Overview of key differences in the approval of a medical device in the EU and USA. Where do combination products and in vitro diagnostics sort in? Register now for free!
Renewed award of SME scholarships to two students of the master's program in biotechnology at Mannheim University of Applied Sciences. Opportunity to get to know gempex at btS ScieCon Digital Herbst on October 21.
...and thus creates the necessary proximity, in particular to the centres of modern biotechnology. Expertise in EU-GMP, US FDA and Chinese regulations directly on site.
Know How! gempex in an technical interview on the question how the effort of GMP compliant qualification can be kept as low as possible in order to ensure product quality, whilst maintaining productivity at the same time.
Online seminar on 09|29|2021: gempex presents as GMP expert the areas "basics of cleaning validation, validation master plan and cleaning validation report" - highlighted by helpful practical examples.
Goal-oriented, efficient and good teamwork ensures a high level of trust. Gap analysis, list of measures and concept SOP, creation of QM documents, GDP trainings, qualification IT infrastructure, GDP consultancy
