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

2022-09-26

DUBLIN, Sept. 26, 2022 /PRNewswire/ -- The "Computer System Validation (CSV) and Data Integrity for Clinical Trials Regulated by FDA Course" training has been added to

ResearchAndMarkets.com's offering.

Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacturing, testing, and distribution of a product in the pharmaceutical, biotechnology, medical device, or other FDA-regulated industries. The 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 FDA in 1997 and disseminated through 21 CFR Part 11. This code describes the basic requirements for validating and documenting ER/ES capability in systems used in an FDA-regulated environment.

FDA's recent focus on data integrity during computer system validation inspections and audits has brought this issue to the forefront of importance for compliance of 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 of those systems used in the conduct of the clinical trial which generates documentation for the clinical Trial Master File (TMF).

Why Should You Attend this virtual seminar?

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

We will also walk through the entire set of essential clinical trial files that must be maintained before, during, and after completion of the trial in the Trial Master File (TMF). This part of the discussion will also delve into the use of electronic Trial Master File (eTMF) systems and the pros and cons of doing so.

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 best efforts are necessary to ensure data is maintained in a state of integrity throughout its lifecycle.

Learning Objectives

Learn how to identify "GxP" Systems

Discuss the Computer System Validation (CSV) approach based on FDA requirements

Learn about the System Development Life Cycle (SDLC) approach to validation

Discuss the 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 through the system's entire life cycle

Learn how to assure the integrity of clinical data that supports trial work

Discuss the importance of "GxP" documentation that complies with FDA requirements

Learn about the policies and procedures needed to support your validation process and ongoing maintenance of your clinical trial systems in a validated state

Understand the key components of 21 CFR Part 11 compliance for electronic records and signatures

Know the regulatory influences that lead to FDA's current thinking at any given time

Learn how to prepare the essential files for a Trial Master File

Understand how an electronic Trial Master File (eTMF) can improve trial management

Know the clinical data files that are essential to collect before, during, and after the conduct of 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

Information Technology 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 System/Application Testers

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

Key Topics Covered:

DAY 1: (10 AM - 03 PM)

Lecture 1:

"GxP" Systems

Computer System Validation (CSV)

CSV Maintenance

Lecture 2:

"GxP" Documentation Principles

Policies and Procedures

Lecture 3:

21 CFR Part 11 Overview

21 CFR Part 11 Compliance