Karin Baas has an extensive experience within several GxP environments; within operations as well as within Quality Assurance.
She worked for the Pharmaceutical Industry, Medical Device Industry and CRO business (pre-clinical, bio-analytical, phase I and late phase).
Experience / subject matter expert for:
- Management variety of QA departments (CRO and Medical Device, R&D and Operations)
- Preparation for Regulatory Inspection (both FDA and Dutch / local GxP authorities)
- Independent auditing (study, investigator site, CRO, subcontractor, supplier)
- QA / auditing clincial trials; Phase I (qualification and study)
- QA / auditing clinical trials; Phase II-IV (qualification and study)
- QA / auditing GLP and GCLP
- Providing GxP training
- Providing gap analysis and CAPA reports
- Assessing Quality Management Systems
- (clinical) Monitoring (CRA at Pharmaceutical Industry)
- Risk Management
- Privacy Legislation / DPIA
[be also referrred to LinkedIn profile]