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).  All of the data and documents supporting the planning, conduct and evaluation of a clinical trial must be of the highest integrity, which must be maintained through their entire life cycle.  Computer System Validation will be discussed as a key methodology for meeting all of these requirements and assuring data/document integrity.

Course Objectives:

• Learn about the components of the TMF and how these are to be created/collected during the process
• Learn about the electronic version, or eTMF, and how this can be built to adequately address all FDA compliance requirements
• Learn about current industry best practices on developing a TMF and/or eTMF and how you can apply these to your process

Why Should You Attend:

You should attend this webinar if you are responsible for establishing or maintaining a TMF, or an electronic version of files (eTMF), 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.

Course Outline:

• GxP Data and Computer Systems Regulated by FDA
• Computer System Validation (CSV)
• The System Development Life Cycle (SDLC) Methodology
• Risk Assessment
• GAMP 5 Software Categorization
• Validation Strategy and Planning
• Functional Requirements Specification (FRS)
• Design/Configuration Specifications
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• System Acceptance and Notification of Release into Production
• Maintenance and Operational Support of FDA-Regulated Computer Systems
• Policies and Procedures to Support CSV
• Training and Organizational Change Management (OCM) Supporting CSV Activities
• 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
• Electronic TMF (eTMF)

What You Get:

• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

Personnel in the following roles will benefit:

• Clinical Research Associates (CRAs)
• Clinical Research Coordinators (CRCs)
• Clinical Research Administrators
• Principal Investigators
• Project Managers
• Sponsors of INDs
• 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