FDA Compliance and Clinical Trials Information System Validation, 2-Day Virtual Seminar February 17-18, 2022 – ResearchAndMarkets.com

DUBLIN – (COMMERCIAL THREAD) – The training “FDA compliance and validation of the clinical trials computer system” has been added to ResearchAndMarkets.com offer.

The FDA governs the computer systems used to collect, analyze, transfer, and report data in support of human clinical trials required 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 for computer systems validation. It involves a rigorous set of phases and steps to ensure that, in the parlance of the FDA, “a system does what it’s supposed to do.”

The cost of properly validating a clinical trial computer system can be high and must be weighed against the risk and use of the system. The GAMP 5 System Classification Guidelines can help ensure that a clinical trial system is appropriately categorized, based on the type of system and technology involved. Along with risk, system classification can provide a clear path for validating a system, depending on the appropriate level of testing and validation effort.

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 Lifecycle (SDLC) methodology used to approach Computer System Validation (CSV), including all phases, event sequencing, deliverables, and documentation requirements.

All types of clinical trial systems will be discussed, 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.

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

At the end of this course, participants should:

  • Understand the FDA requirements for Clinical Trials Information System (CSV) validation

  • Understand the System Development Lifecycle Validation (SDLC) approach

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

  • Understand how to create 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, governing data and 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 operating clinical trial system

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

  • Know the FDA’s trends in monitoring and auditing clinical trial systems and how to stay on top of them

Main topics covered:

FDA oversight of computer systems used in regulated industries

  • “GxP” defined

  • Focus on “GCP”

  • FDA audit and inspection objectives

  • Company compliance objectives

Introduction to Clinical Data Systems (CDS)

Introduction to computer system validation (CSV)

System Development Lifecycle Framework and Validation (SDLC)

  • SDLC phases (requirements, design, test, implementation, acceptance, release into production, change control, retirement)

  • SDLC deliverables, schedule and documentation

  • Requirements Traceability Matrix (RTM) – a key validation deliverable of interest to the FDA

GAMP 5 and classification of systems

System risk assessment and management

  • Clinical data system inventory

  • Risk assessment, mitigation and prioritization

  • System risk monitoring and management across the SDLC of a clinical data system

Build a solid project management plan to frame a clinical data system validation effort

  • Validation strategy and planning

  • Implementation of the clinical data system and execution of the validation

  • Validation documents

  • System and data “owners” and “custodians”

  • Roles and responsibilities

  • Leverage the vendor or other external resource

Integrate business process reengineering principles into the clinical data system validation effort

  • Mapping of clinical processes

  • Looking for opportunities for improvement

  • Integration of improvement into the project plan

Integrate organizational change management (OCM) principles into the clinical data system validation effort

  • Assess the organization’s “appetite” for change

  • Identify “early adopters”, “laggards” and “resistance”

  • Make lasting change

Example – implementation and validation of a clinical data system

Continuous monitoring and management of a clinical data system in a validated state throughout the SDLC

  • Operations and maintenance

  • System and data backup and archiving

  • Change and Best Practices Checklist (top of FDA list for review)

  • Periodic review and assessment for revalidation

  • Policies and procedures (IT and user)

  • Continuing education and OCM

  • Planning and Executing Disaster Recovery (DR)

  • Business Continuity Planning (BCP) and Execution

Systems and Data Governance Council

The strategy and direction of the FDA – the “swinging pendulum”

  • Recent Trends in FDA Findings Related to Clinical Data Systems

  • Factors Influencing FDA Audit and Inspection

  • What does the future look like?

For more information on this training, visit https://www.researchandmarkets.com/r/dpgj6o

About ResearchAndMarkets.com

ResearchAndMarkets.com is the world’s leading source for market research reports and international market data. We provide you with the latest data on international and regional markets, key industries, major companies, new products and the latest trends.

Gordon K. Morehouse