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Two Day Virtual Seminar: FDA Compliance and Clinical Trial Computer System Validation Core Requirements, Expectations and Challenges – August 23-24, 2022 – ResearchAndMarkets.com


DUBLIN–(BUSINESS WIRE)–The “FDA Compliance and Clinical Trial Computer System Validation Core Requirements, Expectations and Challenges” training has been added to by ResearchAndMarkets.com offering.

In this two-day Virtual Seminar you will learn about the FDA’s expectations for the classification, risk assessment, testing, and validation of a computerized system used in clinical trial work. You will learn in detail about the System Development Life Cycle (SDLC) method used to approach Computer System Validation (CSV), including all phases, sequence of events, deliverables, and documentation requirements. .

The FDA manages the computer systems used to collect, analyze, transfer and report data that support human clinical trials required for drug approval. FDA oversight is based on a Predicate Rule, known as “Good Clinical Practices,” or simply, “GCPs.”

Computer systems subject to GCP requirements must be fully and accurately validated in accordance with FDA guidance on computer system validation. It includes a rigorous set of phases and steps to ensure that, in the language of the FDA, “a system does what it is intended to do.”

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

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 discussed in detail.

Continuous maintenance of the system in a valid state will be discussed, as well as management, archival and retirement.

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

Learning Objectives

  • Understand FDA requirements for clinical trial Computer System Validation (CSV)

  • Understand the System Development Life Cycle (SDLC) methodology for validation

  • Use the GAMP 5 system classification and risk methods for categorizing systems and developing a validation path

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

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

  • Learn how to monitor a clinical trial system in production, managing data and systems through retirement

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

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

  • Understand good project management principles, including business process re-engineering and organizational change management in the process

  • Identify the policies and procedures that must be developed and maintained to support a functioning clinical trial system

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

  • Learn about FDA trends in the management and auditing of clinical trial systems and how they will continue

Who Should Attend:

This seminar is intended for those working in FDA-regulated industries, including pharmaceutical, medical device, biological, animal health, organ donation and tobacco. Functions available include research and development, clinical sample preparation, packaging, labeling and distribution, clinical testing and administration, adverse event management and post monitoring. -marketing.

You must attend this seminar if you are responsible for planning, implementing or overseeing the implementation of any clinical trial system governed by FDA regulations, or if you maintain or support such a system. Examples of who can benefit from this webinar include:

  • Data “Owners”

  • Data “Guardians”

  • Information Technology Analysts

  • Information Technology Developers and Testers

  • QC/QA Managers and Analysts

  • Clinical and Scientific Data Managers

  • Analytical Chemists

  • Compliance and Audit Managers

  • Laboratory managers

  • Automation Analysts

  • Computer Systems Validation Specialists

  • GMP Training Specialists

  • Business Stakeholders/Subject Matter Experts

  • Business Systems/Application Testing

This seminar will also benefit any consultants working in the life sciences industry involved in computer system implementation, validation and compliance.

For more information about this training visit https://www.researchandmarkets.com/r/m40njf



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