Consultant

Profile Last Update: 2021-10-08 13:04:22

Auditor Profile

Consultant
Country
United Kingdom
Education
Highest Educational Qualification
University Degree
Language(s)
EnglishNative
FrenchNative
ItalianIntermediate
Regulatory Framework
EU Regulation
US Regulation
Japanese Regulation
Rest of the World
Auditing Experience
38 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 44.44%
Sponsor System or Process Audits 1 11.11%
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 33.33%
For Cause Audits 1 11.11%
GXP Experience
GCP Subject Matter Expert
GLP Previous History
GDP None
GMP None
GVP Previous History
IT/CSV None
Geographical Work Area
EU - EEC Yes
USA & Canada Yes
Asia-Pacific Yes
Japan No
Chile Yes
Panama Yes
Investigational Products
Pharmaceutical Product: Chemical Current Practice
Pharmaceutical Product: Biological Current Practice
Adv. Therapy Medicinal Products Not Applicable
Medical Devices Not Applicable
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 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 Previous History