Independent GCP Auditor
Profile Last Update: 2021-09-03 13:13:37
Auditor Profile
Independent GCP Auditor
Country
Belgium
Education
Highest Educational Qualification
Masters Degree
Masters Degree
Language(s)
FrenchProfessional
EnglishProfessional
GermanElementary
ItalianElementary
Regulatory Framework
| EU Regulation | |
| US Regulation | |
| Japanese Regulation | |
| Rest of the World |
Auditing Experience
24 Years
Availability Time
3 to 6 months
Number of Audits performed in the Last 3 Years
As Lead Auditor15 to 30
As Co-AuditorUp to 15
Number of Audits per Category performed in the Last 3 Years
| Investigator Sites | 20 | 55.56% |
| Sponsor System or Process Audits | 2 | 5.56% |
| Clinical Laboratory Audits (Central/Safety) | 2 | 5.56% |
| Clinical Laboratory Audits (Biomarker, PK/PD) | 1 | 2.78% |
| Investigational Medicinal Product Audit (GMP for IMP) | 0 | 0% |
| Electronic Systems Provider Audit (e.g. eCRF Provider, IVRS/IWRS Provider) | 0 | 0% |
| Vendor/CRO (Full or Part service) | 10 | 27.78% |
| For Cause Audits | 1 | 2.78% |
| Pharmaceutical Product: Chemical | Current Practice |
| Pharmaceutical Product: Biological | Previous History |
| Adv. Therapy Medicinal Products | Previous History |
| Medical Devices | Previous History |
| Consumer Products | Not Applicable |
| Cosmetic Products | Not Applicable |
| Food Stuffs | Previous History |
| Industrial Chemicals | Not Applicable |
| Investigator Site Audits | Current Practice |
| Sponsor System or Process Audits | Current Practice |
| Clinical Laboratory Audits (Central/Safety) | Current Practice |
| Clinical Laboratory Audit (Biomarker, PK/PD) | Current Practice |
| Investigational Medicinal Product Audit (GMP for IMP) | Previous History |
| Electronic Systems Provider Audit (eCRF, IVRS/IWRS,...) | Previous History |
| Vendor/CRO (Full or Part Services) | Current Practice |
| Due Diligence/For Cause Audit | Current Practice |