My professional career began with an apprenticeship as a pharmaceutical production technician. After several years of professional work, I was interested in a new experience, and I decided to study Business Administration and Engineering on a part-time basis in Berlin.
Now, I have been working for more than 22 years in the pharmaceutical industry. The focus of my work lies in the areas of medical devices (including medical software), (drug/device) combination products, pharmaceutical packaging (e.g., quality control, development) and information technologies, including computer validation and software development. These topics form the basis for my publications and the lectures that I offer regularly.
A significant part of my daily work is project management, especially in an international environment. In recent years, my profession has offered me the opportunity to work on different projects. My main activities were:
- the development of a small and customized laboratory information management system (LIMS)
- the development of two different high-volume syringes made of plastic, including filling validation and post-launch optimization
- the introduction of Radio Frequency Identification (RFID) as part of the pharmaceutical packaging for non-logistical applications
- the launch of an electronic auto-injector for patients with multiple sclerosis
- moreover, the launch of two Medical Software products which are used in conjunction with the electronic auto-injector
Currently, I am very interested in regulatory and quality requirements for medical devices (including medical software) and (drug/device) combination products. This includes all aspects, including the introduction of the European Medical Device Regulation (MDR, Regulation 2017/745).
Beyond these topics, I am very interested in specific areas of information technology, including IT security, data privacy, software development, IT quality control, and software testing and validation.
- torstenkneuss_sw_opt: Michael Fricke