Share Your Research, Maximize Your Social Impacts
Main Menu
Searching By
PARTNERS
Clinical Compliance 2011 - Trial Master File for Research Sites: Can You Pass FDA Inspection? - Webinar By ComplianceOnline
Date2011-01-27
Deadline2011-01-27
VenuePalo Alto, USA - United States 
KeywordsClinical Webinar ,conference,event.
Topics/Call fo Papers
Why Should You Attend:
Your clinical trial has zero chance of passing an FDA inspection or QA audit if your Trial Master File (TMF) is not in order.
The FDA frequently states that if compliance isn't documented, it didn't happen. Your TMF serves as living proof that you are adhering to GCP, and that your quality system is in a state of control.
Beyond simply being a get out of jail free card, a well-maintained TMF can make trial management easier; with a typical TMF containing thousands of pages of documentation, you could easily save, or lose, hundreds of hours over the life of a trial searching for individual pieces of knowledge.
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.
Your clinical trial has zero chance of passing an FDA inspection or QA audit if your Trial Master File (TMF) is not in order.
The FDA frequently states that if compliance isn't documented, it didn't happen. Your TMF serves as living proof that you are adhering to GCP, and that your quality system is in a state of control.
Beyond simply being a get out of jail free card, a well-maintained TMF can make trial management easier; with a typical TMF containing thousands of pages of documentation, you could easily save, or lose, hundreds of hours over the life of a trial searching for individual pieces of knowledge.
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.
Other CFPs
- How to Vet an IRB: Expose and Fix Problems Before They Threaten Your Trial
- Design Validation Protocol and Acceptance Criteria for Chromatographic Methods to meet ICH requirements
- Eliminate the Confusion ?Annex 13 GMP guide - Webinar By ComplianceOnline
- 3 hr Webinar on - Garnishments: Complete and In-Depth - Webinar By ComplianceOnline
- ComplianceOnline Virtual Seminar - Auditing and Administrating Human Resource Policies and Practices
Last modified: 2010-12-23 19:33:13