Profile Last Update: 2022-09-05 12:00:34

Auditor Profile

United Kingdom
Highest Educational Qualification
University Degree
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%
GXP Experience
GCP Subject Matter Expert
GLP Previous History
GDP None
GMP None
GVP Previous History
IT/CSV Previous History
Geographical Work Area
EU - EEC Yes
USA & Canada Yes
Asia-Pacific Yes
Japan No
Investigational Products
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
Types of Audits Conducted as Lead Auditor
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