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. 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. FDB3142 Areas Covered in the Session : Trial Master File (TMF) background and rationale Learn what content is required for a TMF for a clinical trial The essential documents to include in a TMF Understand how the essential documents demonstrate the conduct of the regulated activities of the investigator and sponsor Organizing and maintaining a TMF How to provide quality assurance for the data included Standard Operating Procedure required to support TMF Developing a consistent system for locating TMF documents Regulatory Inspection of TMF records and Preparation Industry Standards and Best Practices Interactive Q&A Session Who Should Attend: Lead CRAs CRA Managers Project and/or Study Managers Project and/or Clinical Trial Assistants Clinical Operations Administrators Quality Assurance Personnel Compliance Teams Validation Teams Sponsor and CRO personnel involved in set up, maintenance, and auditing of the Trial Master File for sponsors Consultants Teams involved with CSV Auditors engaged in the internal inspection of clinical trial documentation and practices


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Areas Covered in the Session :

  • Review the current regulatory requirements and guidances (CFR, EU GMPs, ISO, etc.) for environmental monitoring.
  • Discuss issues of sampling methods, selection of sampling sites and the justifications for them.
  • Review the issue of contamination control as an important aspect of EM programs.
  • Discuss the issue of action and alert limits, trending of data and the handling of excursions.
  • What are the most common deficiencies cited by regulatory auditors when auditing environmental monitoring programs?
  • Attendee question and answer period.

Who Should Attend:

  • QA/QC Teams
  • Manufacturing Teams
  • Engineering Teams
  • Validation Teams
  • Regulatory affairs Teams
  • Management Teams
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