GCP/GVP Auditor

Profile Last Update:

Auditor Profile

GCP/GVP Auditor
Highest Educational Qualification
University Degree
Regulatory Framework
EU Regulation
US Regulation
Japanese Regulation
Rest of the World
Auditing Experience
20 Years
Availability Time
Not Available for Hire
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 -4 26.67%
Sponsor System or Process Audits -4 26.67%
Clinical Laboratory Audits (Central/Safety) -2 13.33%
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 20%
For Cause Audits -2 13.33%
GXP Experience
GCP Current Practice
GLP Previous History
GDP None
GMP None
GVP Current Practice
Geographical Work Area
EU - EEC Yes
USA & Canada Yes
Asia-Pacific Yes
Japan Yes
Investigational Products
Pharmaceutical Product: Chemical Current Practice
Pharmaceutical Product: Biological Previous History
Adv. Therapy Medicinal Products Not Applicable
Medical Devices Not Applicable
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 Current Practice
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) Current Practice
Due Diligence/For Cause Audit Current Practice