Head of Study Audit Mgt. EU

Profile Last Update:

Auditor Profile

Head of Study Audit Mgt. EU
Country
Germany
Education
Highest Educational Qualification
Doctorate/PhD
Language(s)
GermanNative
EnglishProfessional
SpanishElementary
Regulatory Framework
EU Regulation
US Regulation
Japanese Regulation
Rest of the World
Auditing Experience
6 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
GXP Experience
GCP Previous History
GLP Previous History
GDP None
GMP None
GVP Previous History
IT/CSV None
Geographical Work Area
EU - EEC Yes
USA & Canada No
Asia-Pacific No
Japan No
Investigational Products
Pharmaceutical Product: Chemical Previous History
Pharmaceutical Product: Biological Not Applicable
Adv. Therapy Medicinal Products Previous History
Medical Devices Previous History
Consumer Products Previous History
Cosmetic Products Not Applicable
Food Stuffs Not Applicable
Industrial Chemicals Not Applicable
Types of Audits Conducted as Lead Auditor
Investigator Site Audits Not Applicable
Sponsor System or Process Audits Not Applicable
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) Not Applicable
Due Diligence/For Cause Audit Not Applicable