Learn valuable insights and strategies from industry experts.
The Trial Master File (TMF) holds the documentation a sponsor needs to show it met its obligations in running a clinical trial. This 90-minute TMF and eTMF training explains what goes in it, how to manage it, and the benefits and challenges of moving to an electronic TMF or keeping a hybrid of paper and eTMF.
You'll review the requirements behind the TMF, including 21 CFR 312.50, European Directive 2005/28/EC and ICH GCP Section 8.1, which defines the documents that let regulators evaluate how a trial was run. The FDA has no specific TMF requirement, but following ICH GCP creates one. TMF records must be available for inspection during and after a trial and support product approval for drugs, biologics, devices and tobacco products.
The session also covers computer system validation for FDA-regulated systems.
Computer system validation
Trial Master File
Attend if you set up or maintain a TMF, or provide quality assurance for the data in it. It also helps anyone who runs clinical trials, audits or inspects trial data and records, or prepares regulatory submissions that include clinical data.
It suits IT, QA/QC, clinical data, regulatory, compliance, validation and risk professionals, trial sponsors, and vendors and consultants in pharmaceutical, biologics, medical device and tobacco product companies.
This webinar is intended for those involved in planning, execution and support of computer system validation activities, working in the FDA-regulated industries, including pharmaceutical, medical device, biologics, tobacco and tobacco-related products (e-liquids, e-cigarettes, pouch tobacco, cigars, etc.). Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, sample labeling, adverse events management and post-marketing surveillance.
Examples of who will benefit from this webinar include:
This webinar will also benefit any vendors and consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance.
Carolyn Troiano has more than 35 years of experience in computer system validation 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. She is currently building an FDA computer system validation compliance strategy at a vapor company. Carolyn has participated in industry conferences, and 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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