Profile Last Update: 2021-10-13 15:27:40

Auditor Profile

Highest Educational Qualification
Masters Degree
Regulatory Framework
EU Regulation
US Regulation
Japanese Regulation
Rest of the World
Auditing Experience
5 Years
Availability Time
3 to 6 months
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 1 14.29%
Sponsor System or Process Audits 3 42.86%
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) 3 42.86%
For Cause Audits 0 0%
GXP Experience
GCP Current Practice
GLP None
GDP None
GMP None
GVP None
Geographical Work Area
EU - EEC Yes
USA & Canada No
Asia-Pacific No
Japan No
Investigational Products
Pharmaceutical Product: Chemical Not Applicable
Pharmaceutical Product: Biological Not Applicable
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 Previous History
Sponsor System or Process Audits Current Practice
Clinical Laboratory Audits (Central/Safety) Not Applicable
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 Not Applicable