Profile Last Update: 2021-10-13 15:27:40
Auditor Profile
Country
Romania
Education
Highest Educational Qualification
Masters Degree
Masters Degree
Language(s)
RomanianNative
GermanNative
EnglishAdvanced
FrenchIntermediate
Regulatory Framework
| EU Regulation | |
| US Regulation | |
| Japanese Regulation | |
| Rest of the World |
Auditing Experience
5 Years
Availability Time
3 to 6 months
Number of Audits performed in the Last 3 Years
As Lead AuditorUp to 15
As Co-AuditorUp to 15
Number of Audits per Category performed in the Last 3 Years
| Investigator Sites | 1 | 14.29% |
| Sponsor System or Process Audits | 3 | 42.86% |
| Clinical Laboratory Audits (Central/Safety) | 0 | 0% |
| Clinical Laboratory Audits (Biomarker, PK/PD) | 0 | 0% |
| 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) | 3 | 42.86% |
| For Cause Audits | 0 | 0% |
| Pharmaceutical Product: Chemical | Not Applicable |
| Pharmaceutical Product: Biological | Not Applicable |
| Adv. Therapy Medicinal Products | Current Practice |
| Medical Devices | Previous History |
| Consumer Products | Not Applicable |
| Cosmetic Products | Not Applicable |
| Food Stuffs | Not Applicable |
| Industrial Chemicals | Not Applicable |
| Investigator Site Audits | Previous History |
| Sponsor System or Process Audits | Current Practice |
| Clinical Laboratory Audits (Central/Safety) | Not Applicable |
| Clinical Laboratory Audit (Biomarker, PK/PD) | Not Applicable |
| Investigational Medicinal Product Audit (GMP for IMP) | Not Applicable |
| Electronic Systems Provider Audit (eCRF, IVRS/IWRS,...) | Not Applicable |
| Vendor/CRO (Full or Part Services) | Current Practice |
| Due Diligence/For Cause Audit | Not Applicable |