Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar
Join us for a webinar on September 10 for a discussion of the webinar
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.”
This seminar will help you understand in detail the new requirements for trial master files.
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
Webinar Takeaways
This webinar will cover the following key areas:
- Learn what content is required for a TMF for a clinical trial
- Understand how the essential documents demonstrate the conduct of the regulated activities of the investigator and sponsor
- Learn how to establish and maintain a well-organized TMF, and provide quality assurance for the data included
- Understand the importance of developing an effective Standard Operating Procedure (SOP) to support TMF activities
- Learn the importance of developing a consistent system for locating TMF documents, and preparing them for study team use or regulatory inspection
- Learn about best practices and industry standards
Who will benefit
Professionals in the following industries may also benefit from the content:
- Pharmaceutical
- Medical Device
- Biotechnology
- Tobacco and Related (Vapor, e-Cigarette, Cigar, etc.)
- Any other FDA-regulated industry, plus any Life Science Consulting or Contracting firm
- Information technology managers and analysts
- QC/QA managers and analysts
- Clinical data managers and scientists
- Compliance managers
- Lab managers and staff
- Automation analysts
- Computer system validation specialists
- GMP training specialists
- Business stakeholders and individuals who are responsible for computer system validation planning, execution, reporting, compliance, and audit
- Consultants working in the life sciences, tobacco and related industries who are involved in computer system implementation, validation and compliance
- Anyone involved in the planning, execution, and reporting of a clinical trial (sponsor, director, researcher, regulatory role, etc.)
Industries who can attend
This 90 -minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.
Carolyn Troiano
Carolyn 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