GCP Audits – Europe
Introduction
Seagen
Seagen is a global biotechnology company dedicated to revolutionizing cancer care. They are Headquartered in the US & Switzerland with a large footprint in the EU.
Apotech consultants:
Our Auditors are all based in the same country the site is located in.
Lead Auditors with over 400 collective GCP audits in the past 5 years.
Types of Audits
- ICH GCP guidelines
Audit Locations
- Europe
Scope of work
Project manage and conduct 10 of Seagen’s European GCP investigator site audits.
Liaise directly with site CRA & PI to arrange the audit date and schedule.
Conduct of the audit, initial meeting, interviews with key members of the site, review of documentation and exit meeting.
Site locations include Spain, Portugal, Belgium, Italy, Netherlands, France & Turkey.
Preparation of worksheets, forms, questionnaires and training.
Audit report and issue of Audit Certificate.
Key numbers
Team
Team of 7
Location
Europe
Length
12 months
Type
Work package