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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
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Scope of work
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Project manage and conduct 10 of Seagen’s European GCP investigator site audits.
![Done Done](https://apotechconsulting.com/wp-content/uploads/Done.png)
Liaise directly with site CRA & PI to arrange the audit date and schedule.
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Conduct of the audit, initial meeting, interviews with key members of the site, review of documentation and exit meeting.
![Done Done](https://apotechconsulting.com/wp-content/uploads/Done.png)
Site locations include Spain, Portugal, Belgium, Italy, Netherlands, France & Turkey.
![Done Done](https://apotechconsulting.com/wp-content/uploads/Done.png)
Preparation of worksheets, forms, questionnaires and training.
![Done Done](https://apotechconsulting.com/wp-content/uploads/Done.png)
Audit report and issue of Audit Certificate.
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Key numbers
![Management Management](https://apotechconsulting.com/wp-content/uploads/Management.png)
Team
Team of 7
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Location
Europe
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Length
12 months
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Type
Work package