GMP Consulting - agil and reliable
As a GMP consultant, I provide on-site advice or take on specific tasks and roles that cannot currently be covered by your staff. My expertise covers a profound knowledge of quality management, various aspects of microbiology in the pharmaceutical industry, and especially validation of computer systems.
Do you have a problem for which you lack the internal know-how?
Outsourcing does not only serve the purpose of increasing resource capacity. It can also provide access to qualified, skilled and experienced personnel at the time when they are needed most. Namely, when issues need to be resolved immediately and there is no time to train internal teams. Let me help you out quickly and easily by bringing in a Pharma Consultant. Call or write an email to firstname.lastname@example.org.
Do you have an urgent project for which you have no resources?
Many of your permanent employees are probably already fully occupied with their daily business. If an additional project is added, for example to increase efficiency or optimize existing processes, it may be that none of your employees has enough free capacity to work in that additional project. As a freelancer, I can step in at any time and drive the project forward for you.
Do you need qualified support at short notice?
Nowadays, flexibility and agility are terms that no modern company can do without. But this is not always easy to implement. In order to be flexible and agile, additional qualified personnel may be needed at short notice, which cannot be hired today and dismissed tomorrow. Dephamon GmbH can be the solution.
Maybe one of your employees would like to take a longer unpaid leave, or a longer maternity or paternity leave? As a temporary contractor I can help you out and bridge this time.
GMP Consulting for Quality Management
The Quality Management System, as described in Eudralex Vol.4 Chapter 1, covers all aspects that can affect the quality of a product. A systematic process for identifying and assessing risks is applied in all areas of manufacturing, such as change management. Changes to a standardized process must be documented in detail and be traceable at all times.
GMP Consulting for Microbiology in the pharmaceutical industry
Microbiology is an important factor in the manufacture of pharmaceutical products, relevant to patient safety, among other factors. Dephamon has extensive experience in all aspects of microbiological contamination control, from cleanroom gowning, cleanroom hygiene and environmental monitoring to optimal design of aseptic work procedures and analysis of intermediate and final products. I can provide comprehensive support for creating a contamination control strategy, ensuring your manufacturing processes meet the highest standards.
Contact me today to learn more about my services and expertise.
GMP Consulting for Computerized System Validation
Computer systems facilitate tasks in offices as well as in laboratories or production facilities of all kinds. Software systems used in GMP-regulated environments must be validated and meet the requirements of Eudralex Volume 4, Annex 11 Computerised Systems or CFR 21 Part 11. The validation of computerized systems according to the GAMP 5 approach is well established in the industry and contains valuable tips for the practical implementation of the regulatory requirements. Press the following button and you will find useful information on the subject of computerized system validation.