Research Sites FDA Inspection - Webinar By ComplianceOnline (Clinical Compliance)
Venue: Online Event
|Event Date/Time: Jun 27, 2012||End Date/Time: Jun 27, 2012|
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. We will review 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. You will learn the steps to take throughout a trial to ensure your TMF will pass inspection by FDA investigators and QA auditors.