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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). This webinar will help you understand in detail the new requirements for trial master files. 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 following the general investigational plan and protocols contained in the IND."
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.
Personnel in the following roles will benefit:
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.
