GXP Auditor & Trainer
Profile Last Update:
Auditor Profile
GXP Auditor & Trainer
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
27 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 | 5 | 16.67% |
| Sponsor System or Process Audits | 8 | 26.67% |
| Clinical Laboratory Audits (Central/Safety) | 3 | 10% |
| Clinical Laboratory Audits (Biomarker, PK/PD) | 3 | 10% |
| 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) | 8 | 26.67% |
| For Cause Audits | 3 | 10% |
| Pharmaceutical Product: Chemical | Current Practice |
| Pharmaceutical Product: Biological | Current Practice |
| Adv. Therapy Medicinal Products | Current Practice |
| Medical Devices | Not Applicable |
| Consumer Products | Previous History |
| Cosmetic Products | Previous History |
| Food Stuffs | Not Applicable |
| Industrial Chemicals | Previous History |
| Investigator Site Audits | Not Applicable |
| Sponsor System or Process Audits | Subject Matter Expert |
| Clinical Laboratory Audits (Central/Safety) | Subject Matter Expert |
| Clinical Laboratory Audit (Biomarker, PK/PD) | Subject Matter Expert |
| 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 |