Karin Baas, M.Sc.
Quality & Risk Management zw-frl
Independent Consultant
QA Specialist
GxP consultancy - auditing - training
doing the right things right — efficiency and effectiveness in GxP
Independent Consultant QA specialist
doing the right things right — efficiency and effectiveness in GxP
QUALITY & RISK MANAGEMENT zw-frl is a company which offers independent Quality Assurance and Risk Management consultancy to life science companies.
Our specialty is delivering dedicated Q-support to life science business; we provide quality and risk management support and provide support in pre-clinical and clinical research arena, both human and veterinary.
Quality Management Systems:
GCP, GLP, GMP, GCLP (EMA reflection paper EMA/INS/GCP/532137/2010 and RQA GCLP), VICH GCP
ISO 17025 and Quality related ISO's
Service in several areas:
- Auditing clincial trials Phase I (CRO or clinical / horspital setting)
- Auditing clinical trials Phase II-IV
- Auditing GLP
- Auditing ISO 17025; in combination with GLP
- Remote auditing
- GxP training
- Quality Management System support / assessment / gap analysis
- Risk Management guidelines (NEN-EN-IEC 31000_2018)
- RIsk Management techniques (NEN-EN-IEC 31010)
- CAPA management
- Standard operation procedure (writing, review and overview)
- Preparation for inspection support
- Consultancy (GxP and Risk Management)