GVP/GCP Consultant

Profile Last Update:

Auditor Profile

GVP/GCP Consultant
Country
Switzerland
Education
Highest Educational Qualification
School Certificate
Language(s)
GermanNative
EnglishProfessional
Regulatory Framework
EU Regulation
US Regulation
Japanese Regulation
Rest of the World
Auditing Experience
26 Years
Availability Time
Not Available for Hire
Number of Audits performed in the Last 3 Years
As Lead Auditor30 or more
As Co-Auditor30 or more
Number of Audits per Category performed in the Last 3 Years
Investigator Sites 5 11.63%
Sponsor System or Process Audits 10 23.26%
Clinical Laboratory Audits (Central/Safety) 5 11.63%
Clinical Laboratory Audits (Biomarker, PK/PD) 3 6.98%
Investigational Medicinal Product Audit (GMP for IMP) 0 0%
Electronic Systems Provider Audit (e.g. eCRF Provider, IVRS/IWRS Provider) 3 6.98%
Vendor/CRO (Full or Part service) 15 34.88%
For Cause Audits 2 4.65%
GXP Experience
GCP Current Practice
GLP Current Practice
GDP Current Practice
GMP Previous History
GVP Current Practice
IT/CSV Current Practice
Geographical Work Area
EU - EEC Yes
USA & Canada Yes
Asia-Pacific Yes
Japan Yes
Israel Yes
Ukraine Yes
Investigational Products
Pharmaceutical Product: Chemical Current Practice
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 Current Practice
Clinical Laboratory Audits (Central/Safety) Current Practice
Clinical Laboratory Audit (Biomarker, PK/PD) Current Practice
Investigational Medicinal Product Audit (GMP for IMP) Not Applicable
Electronic Systems Provider Audit (eCRF, IVRS/IWRS,...) Current Practice
Vendor/CRO (Full or Part Services) Current Practice
Due Diligence/For Cause Audit Current Practice