Kim Lauritzen

Bellatriks Project Management, GxP & Validation Partner

Bellatriks is an independent consultant company that offers Project Management and GxP services e.g. GMP, GDP and Validation to Quality Assurance and Manufacturing organisation in pharmaceutical and Medical Devices companies. We have many years of experience gathered in Consulting Engineers e.g. NNE Pharmaplan, Niras and renowned Pharmaceutical and Medical Device companies, e.g. Novo Nordisk A/S, Lundbeck A/S, Codan Medical ApS. Industries: Aseptic / Sterile manufacture Biotechnological production API production Medical Devices Combination Products We can support you e.g. by: Fast track project management, revamps of plants within the pharmaceutical and confectionary area in close cooperation with manufacturing and R&D. Turn key project management within the pharmaceutical industry. Facilitating project workshops and design reviews to ensure that all requirements are met for all stakeholders. Prepare for an FDA or EU GMP Inspection, perform Internal Audit. Perform Supplier Audit or Quality Assessment at CMO on behaft of the client. Support your QA organisation with QP/QA tasks regarding review of Batch Record, APR/PQR Perform validation tasks in Cleaning / Sterilization / Transport processes. Perform Computer Systems Validation acc. to GAMP 5, FDA 21 CFR Part 11 and EU GMP Vol. IV Annex 11. Writing Validation Master Plan, Validation Master Plan Report, Validation Plan, Validation Plan Report etc. Writing SOP's, Non Conformities (deviations), Incl. Root Cause Analysis Mapping Temperature of warehouses and cold rooms. Giving on-site GMP, GDP and Validation Training/Workshop to the Pharmaceutical, Medical Device.