Clinical Trial Master File Compliance

01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar

"Listen By Carolyn Troiano industry reviewer for 21 CFR Part 11, the FDA’s (ER/ES) regulation. along with computer system validation and risk management/compliance at a number of Fortune 100 firms"

Providing quality assurance for data included in the file

Description

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/are conducted in accordance with the general investigational plan and protocols contained in the IND."

Objectives

•          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

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

•          Trial Master File (TMF) background and rationale
•          The essential documents to include in a TMF
•          Organizing and maintaining a TMF
•          Standard Operating Procedure required to support TMF
•          Inspection of TMF records
•          Q&A

Who will Benefit

•          Personnel in the following roles will benefit:
                •       Information Technology (IT) Analysts
                •       IT Developers
                •       IT 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
                •       Business Stakeholders using Computer Systems regulated by FDA
                •       Regulatory Affairs Personnel
                •       Consultants in the Life Sciences and Tobacco Industries
                •       Interns working at the companies listed above
                •       College students attending schools and studying computer system validation, regulatory                                              affairs/matters (related to FDA) or any other discipline that involves adherence to FDA regulatory                                 requirements

Industries who can attend

This 90-minute online course is intended for professionals in the Medical Device, Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.


Speaker Profile

Carolyn Troiano

Carolyn Troiano has more than 35 years of experience in computer system validation in the pharmaceutical, medical device, animal health and other FDA-regulated industries. She is currently managing a large, complex data migration, analytics and reporting program at a major financial institution.

During her career, Carolyn worked directly, or as a consultant, for many top-tier pharmaceutical companies in the US and Europe. She was responsible for computer system validation across all GxP functions at a major pharmaceutical company. Carolyn developed validation programs and strategies back in the mid-1980s, when FDA guidelines were first issued. She was an industry reviewer for 21 CFR Part 11, the FDA’s electronic record/electronic signature (ER/ES) regulation. She has taught ER/ES compliance, along with computer system validation and risk management/compliance at a number of Fortune 100 firms. Her experience includes work with FDA-regulated systems used in all areas of research, development, manufacturing, quality testing and distribution.

Carolyn has participated in industry conferences, providing very creative and interactive presentations. She is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area. Carolyn also volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.

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