Computer System Validation (CSV) and Data Integrity Course for FDA Regulated Clinical Trials (October 13-14, 2022)

DUBLIN, September 26, 2022 /PRNewswire/ — “Computer System Validation (CSV) and Data Integrity for FDA Regulated Clinical Trials Course” course has been added to from offer.

Validation of computer systems has been regulated by the FDA for over 30 years as it pertains to systems used in the manufacturing, testing, and distribution of a product in the pharmaceutical, biotechnology, medical device, or other industries. regulated by the FDA. FDA requirements ensure thorough planning, implementation, integration, testing, and management of computer systems used to collect, analyze, and/or report data.

Electronic records and electronic signatures (ER/ES) came into play through guidelines established by the FDA in 1997 and disseminated through 21 CFR Part 11. This code outlines the basic requirements for validating and documenting the ER/ES capability in systems used in an FDA regulated environment. environment.

The FDA’s recent emphasis on data integrity during inspections and validation audits of computer systems has brought this issue to the forefront of compliance importance for systems used to support clinical trials. These include clinical trial data collection, management and reporting systems, clinical trial sample manufacturing, testing and labeling systems, and all systems used in the conduct of clinical trials. clinical trial that generate documentation for the Clinical Trial Master File (TMF).

Why should you attend this virtual seminar?

We will explore best practices and strategic approaches to assess IT systems used in the conduct of clinical trials and determine the level of compliance, based on validation and data integrity. We will review the entire System Development Life Cycle (SDLC) approach to validation of FDA-regulated computer systems, and also discuss 21 CFR Part 11 and the importance of managing records. and electronic signatures appropriately.

We will also review all of the essential clinical trial records that must be kept before, during and after the end of the trial in the Trial Master File (TMF). This part of the discussion will also look at the use of electronic Trial Master File (eTMF) systems and the pros and cons of such use.

Finally, we will discuss what is needed to prepare for an FDA inspection of computer systems and data used in support of clinical trials. These are extremely valuable assets for any company doing this type of work, and every effort is needed to ensure that the data is maintained in a state of integrity throughout its lifecycle.

Learning objectives

  • Learn to identify “GxP” systems
  • Discuss Computer System Validation (CSV) approach based on FDA requirements
  • Learn more about the System Development Life Cycle (SDLC) approach to validation
  • Discuss best practices for documenting computer system validation efforts, including requirements, design, development, testing, and operational maintenance procedures
  • Understand how to maintain a system in a validated state throughout the system lifecycle
  • Learn how to ensure the integrity of clinical data that supports trial work
  • Discuss the importance of FDA-compliant “GxP” documentation
  • Learn about the policies and procedures needed to support your validation process and the ongoing maintenance of your clinical trial systems in a validated state
  • Understand the key elements of 21 CFR Part 11 compliance for electronic records and signatures
  • Know the regulatory influences driving current FDA thinking at any given time
  • Learn how to prepare essential files for a Trial Master File
  • Understand how an electronic test master file (eTMF) can improve test management
  • Know the essential clinical data files to collect before, during and after conducting a trial
  • Learn how to best prepare for an FDA inspection or audit of a clinical trial-related computer system.

Who should attend:

  • Clinical data analysts
  • Clinical Data Managers
  • Clinical Trial Sponsors
  • Information technology analysts
  • IT developers and testers
  • QC/QA managers and analysts
  • Analytical chemists
  • Compliance and Audit Managers
  • Laboratory managers
  • Automation analysts
  • Computer system validation specialists
  • GMP Training Specialists
  • Business Stakeholders/Subject Matter Experts
  • Business systems/application testers
  • This seminar will also benefit all consultants working in the life science industry who are involved in the implementation, validation and compliance of IT systems.

Main topics covered:

DAY 1 : (10:00 a.m. – 3:00 p.m.)

Course 1:

  • “GxP” systems
  • Computer System Validation (CSV)
  • CSV interview

Course 2:

  • Principles of “GxP” documentation
  • Policies and Procedures

Course 3:

  • 21 CFR Part 11 Overview
  • 21 CFR Part 11 Compliance
  • FDA regulatory compliance

DAY 2: (10:00 a.m. – 3:00 p.m.)

Lecture 4:

  • Computers and Data Integrity
  • Regulatory influences
  • Industry Best Practices

Lecture 5:

  • Clinical Trial Master File (TMF)
  • Electronic Test Master File (eTMF)
  • Contents of main test file
  • Before the start of the clinical trial
  • During the clinical trial
  • After the clinical trial

Lecture 6:

  • Preparing for an IT system audit

For more information on this training visit

Media Contact:

Research and Markets
Laura Woodsenior
[email protected]

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SOURCE Research and Markets

Gordon K. Morehouse