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)