4-Hour Virtual Seminar on Computer System Validation (CSV) and Data Integrity for Clinical Trials Regulated by FDA

Computer systems used in conducting clinical trials must be evaluated to determine the level of compliance, established on validation and data integrity. We will walk through the entire System Development Life Cycle (SDLC) approach to validation of FDA-regulated computer systems. This webinar will also focus on 21 CFR Part 11 and the significance of managing electronic records and signatures appropriately. We will cover all the essential clinical trial files that must be maintained before, during and after completion of the trial in the Trial Master File (TMF). This discussion will take you through the use and transition to an electronic Trial Master File (eTMF) system. The pros and cons will be evaluated. Finally, how to prepare for a computer systems FDA inspection and its data used to support clinical trials will be discussed. Due diligence is extremely necessary to ensure data integrity is maintained throughout its life-cycle.

Areas Covered in the Session : 

• 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

Seminar Agenda:

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

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

Course Director: CAROLYN TROIANO ‎

Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects. During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation. Carolyn has participated in industry conferences. She is currently active in the PMI, AITP, and RichTech, and volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.