Independent GCP Auditor

Profile Last Update: 2021-10-20 16:36:07

Auditor Profile

Independent GCP Auditor
Country
Belgium
Education
Highest Educational Qualification
Masters Degree
Language(s)
DutchNative
EnglishProfessional
FrenchProfessional
ItalianElementary
Regulatory Framework
EU Regulation
US Regulation
Japanese Regulation
Rest of the World
Auditing Experience
24 Years
Availability Time
3 to 6 months
Number of Audits performed in the Last 3 Years
As Lead Auditor30 or more
As Co-AuditorUp to 15
Number of Audits per Category performed in the Last 3 Years
Investigator Sites 20 55.56%
Sponsor System or Process Audits 2 5.56%
Clinical Laboratory Audits (Central/Safety) 2 5.56%
Clinical Laboratory Audits (Biomarker, PK/PD) 1 2.78%
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) 10 27.78%
For Cause Audits 1 2.78%
GXP Experience
GCP Current Practice
GLP Previous History
GDP Previous History
GMP Previous History
GVP Previous History
IT/CSV Previous History
Geographical Work Area
EU - EEC Yes
USA & Canada No
Asia-Pacific No
Japan No
Israel Yes
Ukraine Yes
Investigational Products
Pharmaceutical Product: Chemical Current Practice
Pharmaceutical Product: Biological Previous History
Adv. Therapy Medicinal Products Previous History
Medical Devices Previous History
Consumer Products Not Applicable
Cosmetic Products Not Applicable
Food Stuffs Previous History
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) Current Practice
Clinical Laboratory Audit (Biomarker, PK/PD) Current Practice
Investigational Medicinal Product Audit (GMP for IMP) Previous History
Electronic Systems Provider Audit (eCRF, IVRS/IWRS,...) Previous History
Vendor/CRO (Full or Part Services) Current Practice
Due Diligence/For Cause Audit Previous History