References
For several years Dephamon GmbH has been supporting various companies in setting up and optimizing their quality systems/processes as well as in project management for the implementation of new systems.
Support during Swissmedic inspection
Laboratory management during the establishment of a new laboratory for microbiological analyses according to GMP for environmental monitoring, pharmaceutical water and pharmaceutical products. Supervision during the successful Swissmedic initial inspection with subsequent receipt of the operating license.
Duration: 9 months from start Implementation of the quality management for the laboratory incl. qualification of the analytical equipment, validation of the LIMS system and method verifications.
Introduction and validation of new LIMS
Project management for the evaluation, implementation and validation of a LIMS software at a manufacturer of pharmaceutical products.
Duration: 12 months
Client feedback: “Danke für die professionelle Art und Weise, wie das Projekt geführt und die Dokumente erstellt wurden. Das war super!”
GAP Analysis of an existing microbiology laboratory
Conduct a GAP analysis regarding the safety and cleanliness of an existing microbiology laboratory with recommendations to optimize process flows, safety and cleanliness based on a priority list.
Duration: 2 months
Client feedback: Overall rating of Dephamon GmbH: Very good!
Process optimization
External GMP expert for QA issues at a medicinal products manufacturer. Optimization of processes in general quality management by 1) analysis of existing processes, 2) identification of weaknesses and gaps in relation to regulatory requirements 3) redesign in cooperation with the involved persons.
Establishment of various concepts and documents, especially in the areas of deviation and change management, supplier qualification, risk management, employee training and self-inspections.
Duration: 16 months
Client feedback: “We were extremely pleased to have the opportunity to work with Tamara because she could provide us a very high level of support in a very wide range of topics. She was very focused on our issues and could bring efficient solutions that were perfectly sticking to our way of working.
We would like to thank you very much for the high quality, humbleness, kindness and proactivity in the support you provided to us!”
