Organize and Presented By
247compliance
Sponsored By
247compliance
Organizing/Related Departments
Medical Device Resource
Organization Type
Event Organizing Company
WebinarCategory
Non Technical
WebinarLevel
All (State/Province/Region, National & International)
Related Industries
Medical/Healthcare/Hospital
OTHERS
Location
Newark, Delaware, United States
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.
- 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
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.
- 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
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
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.
Registration Fees
Available
Registration Fees Details
Live session for 1 participant
$199
Live + Recorded Session
$269
Live + Transcript
$249
Live + Training CD
Free shipment within 72 hours from the date of webinar completion.
$450
On Demand Options
Transcript
$179
Downloadable recorded session
$239
Training CD
Free shipment within 72 Hours, from the date of webinar completion
$350
Group Session unlimited participants + Recorded
$799
Registration Ways
Email
Phone
Website
Other
Address/Venue
247compliance
2035 Sunset Lake,
RoadSuite B-2,
Newark,
Delaware - 247compliance
Pin/Zip Code : 247compliance