Profile Last Update: 2021-10-05 14:11:59

Auditor Profile

Highest Educational Qualification
School Certificate
Regulatory Framework
EU Regulation
US Regulation
Japanese Regulation
Rest of the World
Auditing Experience
13 Years
Availability Time
Not Available for Hire
Number of Audits performed in the Last 3 Years
As Lead Auditor15 to 30
As Co-Auditor30 or more
Number of Audits per Category performed in the Last 3 Years
Investigator Sites 10 9.43%
Sponsor System or Process Audits 12 11.32%
Clinical Laboratory Audits (Central/Safety) 15 14.15%
Clinical Laboratory Audits (Biomarker, PK/PD) 12 11.32%
Investigational Medicinal Product Audit (GMP for IMP) 11 10.38%
Electronic Systems Provider Audit (e.g. eCRF Provider, IVRS/IWRS Provider) 15 14.15%
Vendor/CRO (Full or Part service) 1 0.94%
For Cause Audits 30 28.3%
GXP Experience
GCP Current Practice
GLP Current Practice
GDP Current Practice
GMP None
GVP Subject Matter Expert
IT/CSV Subject Matter Expert
Geographical Work Area
EU - EEC Yes
USA & Canada No
Asia-Pacific No
Japan Yes
Antigua and Barbuda Yes
Bahrain Yes
Investigational Products
Pharmaceutical Product: Chemical Current Practice
Pharmaceutical Product: Biological Not Applicable
Adv. Therapy Medicinal Products Not Applicable
Medical Devices Not Applicable
Consumer Products Subject Matter Expert
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 Current Practice
Clinical Laboratory Audits (Central/Safety) Previous History
Clinical Laboratory Audit (Biomarker, PK/PD) Not Applicable
Investigational Medicinal Product Audit (GMP for IMP) Previous History
Electronic Systems Provider Audit (eCRF, IVRS/IWRS,...) Current Practice
Vendor/CRO (Full or Part Services) Not Applicable
Due Diligence/For Cause Audit Not Applicable