Day 1: 10:00 AM - 03:00 PM

Day 2: 10:00 AM - 03:00 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
– FDA Regulatory Compliance

Lecture 4:
– Computers and Data Integrity
– Regulatory Influences
– Industry Best Practices

Lecture 5:
– Clinical Trial Master File (TMF)
– Electronic Trial Master File (eTMF)
– Trial Master File Content
– Before the Clinical Trial Begins
– During the Clinical Trial
– After the Clinical Trial

Lecture 6:
– Prepare for a Computer System Audit


Computer system validation has been regulated by FDA for more than 30 years, used in the pharmaceutical, biotechnology, medical device, and other FDA-regulated industries for manufacturing, testing, and distributing products. This validation process encompasses thorough planning, implementation, integration, testing, and management of computer systems used to collect, analyze, and report data.

Guidelines established by the FDA in 1997, disseminated through 21 CFR Part 11, introduced the concept of electronic records and electronic signatures (ER/ES) and set out the basic requirements for validating and documenting their capability in systems used in FDA-regulated environments.

In recent years, the FDA has shifted its focus to data integrity during computer system validation inspections and audits, making it a crucial aspect of compliance for systems supporting clinical trials. These include systems for clinical trial data collection, management, and reporting, as well as those used for clinical trial sample manufacturing, testing, and labeling, and all systems generating documentation for the clinical Trial Master File (TMF).

Why Should You Attend:

In this seminar, we will cover the best practices and strategic approaches for evaluating computer systems used in clinical trials and determining their level of compliance based on validation and data integrity. We will take a deep dive into the System Development Life Cycle (SDLC) approach to validating FDA-regulated computer systems and explore the importance of managing electronic records and signatures in compliance with 21 CFR Part 11.

Additionally, we will examine the set of essential clinical trial files that must be maintained before, during, and after trial completion in the Trial Master File (TMF). Our discussion will also include the use of electronic Trial Master File (eTMF) systems, weighing the pros and cons of using such systems.

Finally, we will discuss the necessary preparations for an FDA inspection of computer systems and data used in support of clinical trials. These systems and data are critical assets for any company conducting clinical trials, and maintaining data integrity throughout its lifecycle is crucial for success.

Seminar 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 :

This seminar is intended for those involved in clinical trial planning, execution and support, working in the FDA-regulated industries, including pharmaceutical, medical device, biological and tobacco. Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, clinical sample labeling, adverse events management and post-marketing surveillance. 

You should attend this seminar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations that is used to conduct, manage or support the conduct of clinical trials, or if you are maintaining or supporting such a system. Examples of who will benefit from this webinar include:

  • 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.
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