Two-Day Virtual Seminar: Basic Requirements, Expectations, and Challenges of FDA Compliance and Clinical Trial IT System Validation – August 23-24, 2022 –


DUBLIN–(BUSINESS WIRE)–FDA Compliance and Clinical Trial Computer System Validation Core Requirements, Expectations and Challenges training has been added to from offer.

During this two-day virtual seminar, you will learn about the FDA’s expectations for classification, risk assessment, testing, and validation of a computer system used in clinical trials. You will learn in detail the System Development Life Cycle (SDLC) methodology used to approach Computer System Validation (CSV), including all phases, sequencing of events, deliverables, and documentation requirements.

The FDA regulates computer systems used to collect, analyze, transfer, and report data supporting human clinical trials necessary for drug approval. FDA oversight is based on a predicate rule, known as “good clinical practice” or simply “GCP.”

Computer systems subject to GCP requirements must be thoroughly and appropriately validated in accordance with FDA guidelines on computer system validation. It involves a rigorous set of phases and steps to ensure that, in FDA parlance, “a system does what it’s supposed to do.”

The cost of properly validating a clinical trial informatics system can be high and must be weighed against the risks and use of the system. The GAMP 5 system classification guidelines can help ensure that a clinical trial system is classified appropriately, depending on the type of system and technology involved. Along with risk, system classification can provide a clear path to validate a system, based on the appropriate level of testing and validation effort.

All types of clinical trial systems will be covered, including in-house developed code, configurable systems, and custom designed systems. Industry best practices and potential pitfalls in validating clinical trial systems, along with examples, will be covered in detail.

Ongoing maintenance of the system in a validated state will be discussed, as well as governance, archiving and retirement.

We will also discuss the importance of applying good project management, business process reengineering, and organizational change management principles throughout the validation process and beyond.

Learning objectives

  • Understand the FDA requirements for computer system validation (CSV) of clinical trials

  • Understand the System Development Life Cycle (SDLC) validation approach

  • Use GAMP 5 systems classification and risk methodologies to categorize systems and develop a validation pathway

  • Understand how to develop a comprehensive validation strategy and program for clinical trial systems

  • Know how to manage the validation process and create FDA compliant documentation

  • Know how to monitor a clinical trial system in production, manage data and the system until retirement

  • Understand the roles and responsibilities required to validate a clinical trial system

  • Know how to measure cost versus compliance risk for a clinical trial system

  • Understand good project management principles, integrating business process reengineering and organizational change management into the process

  • Know the policies and procedures that must be developed and maintained to support the clinical trial system in operation

  • Understand how to leverage vendor and other external resources to apply industry best practices and avoid potential pitfalls when validating a clinical trial system

  • Know FDA trends in monitoring and auditing clinical trial systems and know how to keep up to date with them

Who should attend:

This seminar is intended for individuals working in FDA-regulated industries, including pharmaceuticals, medical devices, biologics, animal health, organ donation, and tobacco. Applicable functions include research and development, clinical sample manufacturing, packaging, labeling and distribution, clinical testing and management, adverse event management, and post-marketing surveillance.

You should attend this seminar if you are responsible for planning, executing, or managing the implementation of any clinical trial system governed by FDA regulations, or if you maintain or support such system. Here are some examples of people who will benefit from this webinar:

  • “Owners” of the data

  • Data “stewards”

  • Information technology analysts

  • IT developers and testers

  • QC/QA managers and analysts

  • Clinical and scientific data managers

  • 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 sciences industry who are involved in the implementation, validation and compliance of IT systems.

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