About Me
I have a Master of Science in Biology from University of Copenhagen,
and previous to this degree I have worked in pharmacies in Denmark as a pharmacy technian.
I have more than 20+ years of experience from both pharmacy, large and small companies within the
pharmaceutical industry and the device area as well as consultancy projects in previous jobs.
I have a special interest in Microbiology - and especially microbiological challenges related to production of Medical Cannabis and support the Medical Cannabis industry complying to EMA GMP standards, and getting their products approved by the Danish Health and Medicines Authority.
My expertise is based on
- Experience from different areas of quality assurance/regulatory affairs in the life science industry and consultancy projects
- Global project experience from minor/major projects in international companies.
- Jobs at different level in the industry
With focus on compliance, I have gained extensive knowledge of ISO standards, cGMP/cGDP and medical device and drug regulation by FDA and/or local European agencies.
I have several years of experience peforming audits, evaluation and approval of various suppliers and contractors incl. preparation of relevant contracts.
My competences range from basic coordination and planning at hands-on level to interim management including training and education of employees, and to the decision and implementation of initiatives at strategic levels
Ways2Compliance ApS
CVR no. 40946063
