Profileimage by Kamal Shahani GCP Consultant / GCP Auditors / GCP Audits / Pharmacovigilance Audits / GLP / GMP Audits from

Kamal Shahani

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Last update: 20.06.2018

GCP Consultant / GCP Auditors / GCP Audits / Pharmacovigilance Audits / GLP / GMP Audits

Company: CRQA
Graduation: not provided
Hourly-/Daily rates: show
These are India rates. Rates may vary for US / Europe and other markets and activities.
Languages: English (Native or Bilingual)

Skills

www.crqa.in

?GCP AUDITS:
?Investigator Sites, IRB/IEC, Document Audits, Vendor, CRO (Phase I and/or BA/BE units)
?For Cause Audits
?Vendor Audits:
?Contract Research Organization Audits 
?Central Laboratory Audits
?Clinical Trial Supply Audits 
?Independent Ethics Committee Audits
?
?Clinical Data Management & Biostatistics Audits
?GCP AUDITS:
?Investigator Sites, IRB/IEC, Document Audits, Vendor, CRO (Phase I and/or BA/BE units)
?For Cause Audits
?Vendor Audits:
?Contract Research Organization Audits 
?Central Laboratory Audits
?Clinical Trial Supply Audits 
?Independent Ethics Committee Audits
?
?Clinical Data Management & Biostatistics Audits

Phamacovigilance Audits 

 
?Global Pharmacovigilance audit
?MAH audit
?QPPV audit
?Company affiliates audit
?Business partner/Marketing partner audit
?Vendor/Service provider audit (Literature search, Case processing Unit, Translations, Vendor (PSUR/PABER/RMP/ADCO, etc.)
?Inspection/audit readiness

The audit program is designed to cover various aspects of clinical data management activities:
 
- EDC Audits
 -Database Set-up Audits
-Data Management In-Trial Audits
-Database Lock Audits
-System
-Process Audits
-Biostatistics Audits

Mock Inspections

GMP Audits
GLP Audits
GCP Trainings

Project history

Strong GCP Audits experience with several global clients. References would be provided upon request.

Time and spatial flexibility

Auditors are availale for India, China, South East Asia

Other

Please refer to our website - www.crqa.in

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