Trial Master File for Clinical Data Systems Regulated by FDA 2018 is a webinar that covers topics such as:
- How the essential documents demonstrate the conduct of the regulated activities of the investigator and sponsor
- What content is required for a TMF for a clinical trial
- The importance of developing an effective Standard Operating Procedure (SOP) to support TMF activities
- How to establish and maintain a well-organized TMF, and provide quality assurance for the data included
- Best practices and industry standards
- The importance of developing a consistent system for locating TMF documents, and preparing them for study team use or regulatory inspection
Trial Master File for Clinical Data Systems Regulated by FDA 2018 is intended for:
- IT Developers
- Information Technology (IT) Analysts
- QC/QA Managers and Analysts
- IT Support Staff
- Compliance Managers and Auditors
- Clinical Data Managers and Scientists
- Computer System Validation Specialists
- Lab Managers and Analysts
- Business Stakeholders using Computer Systems regulated by FDA
- GMP Training Specialists
- Consultants in the Life Sciences and Tobacco Industries
- Regulatory Affairs Personnel
- College students
- Interns working at the companies listed above
