Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements.Certain documents, content and images related to a clinical trial must be stored and maintained, and depending on the regulatory jurisdiction, this body of information may be stored in a trial master file (TMF). The TMF includes all of the documentation that a sponsor must record to demonstrate that they have met their obligations for the conduct of a clinical trial. The Code of Federal Regulations states in 21 CFR 312.50: "Sponsors are responsible for ensuring that the investigation(s) is conducted in accordance with the general investigational plan and protocols contained in the IND."
Why should you Attend:
You should attend this webinar if you are responsible for establishing or maintaining a TMF, or providing quality assurance for data included in the file. This webinar will also benefit those involved in the conduct of clinical trials, audit and inspection of clinical trial study data and records, and submission of filings to regulatory agencies that involve clinical trial data.
Areas Covered in the Session:
Learn what content is required for a TMF for a clinical tria
Learn about best practices and industry standards
Understand the importance of developing an effective Standard
Who Will Benefit:
T Support Staff
QC/QA Managers and Analysts
Clinical Data Managers and Scientists
Compliance Managers and Auditors
Lab Managers and Analysts
Computer System Validation Specialists
GMP Training Specialists
Carolyn (McKillop) Troiano has more than 35 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs.
Compliance4All DBA NetZealous,