Profile Last Update: 2022-09-05 12:00:34
Auditor Profile
Country
United Kingdom
Education
Highest Educational Qualification
University Degree
University Degree
Language(s)
EnglishNative
Regulatory Framework
| EU Regulation | |
| US Regulation | |
| Japanese Regulation | |
| Rest of the World |
Auditing Experience
28 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 | 8 | 22.86% |
| Sponsor System or Process Audits | 11 | 31.43% |
| 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) | 14 | 40% |
| For Cause Audits | 2 | 5.71% |
| Pharmaceutical Product: Chemical | Subject Matter Expert |
| Pharmaceutical Product: Biological | Current Practice |
| 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 | Current Practice |
| Sponsor System or Process Audits | Subject Matter Expert |
| Clinical Laboratory Audits (Central/Safety) | Previous History |
| 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) | Subject Matter Expert |
| Due Diligence/For Cause Audit | Current Practice |