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34594 Conferences

Trial Master File for Research Sites: Can You Pass FDA Inspection?

Added by Referral on 2011-01-03

Conference Dates:

Start Date Start Date: 2011-01-27

Conference Contact Info:

Contact Person Contact Person: admin
Email Email:
Address Address: 2600 E. Bayshore Road, Online Event,Palo Alto, CA, 94303, United States
Phone Tel: 650-620-3915
Phone Fax: 650-963-2556

Conference Description:

This course reviews the investigator TMF required and additional content for a clinical trial - the activities of set-up, maintenance, and quality control and assurance will be discussed, as well as common deficiencies and challenges.

In this webinar, you will get guidance on the TMF. Learn the steps to take throughout a trial to ensure your TMF will pass inspection by FDA investigators and QA auditors.

Areas Covered in the Seminar:

Documents that should, and should not, make up a Trial Master File.
Maintenance and quality control of the TMF.
Start smart—the steps to take from Day One to create a compliant and useful TMF.
Red flags that scream "noncompliance".
Common pain points that you can expect to encounter, and how to keep them from driving your TMF into noncompliance.
Note to File (NTF).
CRA contributions to and adequate monitoring of the investigator TMF.

Note: Use these promocode(117660) for 10% discount.
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