Dr. Janet Thode
I supervise the division MedTech, Pharma and Laboratory as partner of Lösungsfabrik Thode and Partners.
The different stations in my life have convinced me that these three topics complement each other in an excellent manner. For all three, quality management is of crucial importance.
With a strong background and experience with a multitude of methods after working in laboratories for many years, I came into contact with GMP, GLP and ISO 17025 in a contract laboratory in France. This awakened my interest in quality management systems and pharmaceutical quality control.
I’ve been able to get deeper insights in the GMP field at a local pharmaceutical company. There, I managed an international method transfer to another pharmaceutical company as well as to a contract manufacturing organization and connected laboratories. That’s why good, open communication belongs to my strengths and the creation of method validation plans and reports as well as the assistance with dossier preparation belong to daily tasks. Other key activities include the field of product filter validation ranging from revising existing documentation in regard to current requirements to evaluating extractables / leachables studies in regard to hazards and concerns.
Due to a previous training in the field of ISO 9001 and as I’m not deterred by the regulated environment, I’ve discovered the parallels between different quality management systems. That’s why I want to use my experience in the laboratory and the GMP field for work in neighboring fields.
Consequently, my focus areas are:
- Method transfers (coordination and documentation, also on an international level)
- Validating analytical methods according to ICH Q2(R1)
- Product filter validation
- Implementation of quality management systems according to ISO 13485 and ISO 17025
If you have any questions, please don’t hesitate to contact us by telephone or e-mail.