CSV and Data Integrity Course Description
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 generate documentation for the clinical Trial Master File (TMF).
Why Should You Attend this virtual seminar
We will explore the best practices and strategic approach 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.
Training Agenda
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
- FDA Regulatory Compliance
DAY 2 : (10 AM – 03 PM)
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 Will Benefit
- 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.
Faculty Carolyn Troiano (34+ yrs exp.)
- Midlothian, Virginia, United States
Award winning FDA Compliance Speaker for Validation, 21 CFR Part 11 (Electronic Records/Signatures) and Data Integrity.
My experience includes 34+ years in IT/ Business, Marketing & Compliance leadership and management roles at a variety of Fortune 100 companies, across multiple industries.
My successes include building and managing teams and business units at multiple “greenfield” sites in the pharmaceutical, biotechnology and IT consulting industries, as well as in the public sector. I have weathered numerous layoffs, mergers and acquisitions, and demonstrated my very strong leadership skills in helping staff get through difficult times.
