If your Trial Master File (TMF) is not in order, there is no chance of your clinical trial passing an FDA inspection or QA audit. Your TMF serves as proof that you are adhering to GCP and that your quality system is in place. A well-maintained TMF can make trial management easier.
In a new BioWorld Today and Medical Device Daily audio conference, speaker Carl Anderson, senior consultant with the Biologics Consulting Group Inc., will provide guidance on the TMF by highlighting some of the pitfalls and pressure points you can expect as you build your TMF.
"Trial Master File: Ensure Your Trial Documentation Will Pass FDA Inspection" is just $349 per listening site. Scheduled for September 3rd, from 1-2:30 p.m., it includes presentation handouts and a half-hour Q&A session with the speaker. A conference CD (MP3 format) is also available. Please call 800-688-2421 or 404-262-5474 and mention conference code T08510.