Clinical Trial Master File Compliance
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Online Compliance Panel
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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.
Objectives of the Presentation
Objectives of the Presentation
- 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
Outline
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
Topic Background
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."
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
Topic Background
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."
Speaker/s
Instructor Profile:
Carolyn Troiano has more than 35 years of experience in the pharmaceutical, medical device, tobacco 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.
Carolyn Troiano has more than 35 years of experience in the pharmaceutical, medical device, tobacco 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.
Special Offer
Webinar Link: https://goo.gl/bMJfhC
Special Offers :
- Use Coupon code " TNOI9Y " to avail a 10% discount on Recorded Session, Training CD or Flash Drive.
- Register For This Webinar & Get 40% Off On Next Upcoming Webinar Purchase - Use ORDER ID as PROMO CODE
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Onlinecompliancepanel is a dedicated team of youngsters, who work in tandem with the latest US FDA regulations/regulatory compliance in creating training sessions suitable for individuals and corporations. These sessions are simple, interactive and cost effective. We are a predominantly web based information exchange forum. Our interactive training sessions could be beneficial to corporations thriving in industries such as pharmaceuticals, drugs and chemicals, FDA compliance, medical devices, packaging and labeling, food and beverages, banking and finance, audits and inspections, recalls and crisis management and many more. We emphasizes in offering regulatory compliance training to compliance professionals on varied topics. These primarily include risk management, quality management, corporate compliance and other regulatory compliances. Some of our primary areas of focus include advancement and updates in regulatory compliance, best practices, risk management and market trends.
Professional training, in the essential quality disciplines, contributes to both the competitiveness of your business and also to personal motivation; it broadens the experience and accelerates the development of those who participate. We provide training in a number of ways: ...
Professional training, in the essential quality disciplines, contributes to both the competitiveness of your business and also to personal motivation; it broadens the experience and accelerates the development of those who participate. We provide training in a number of ways: ...
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