Course Overview
This 2-day online course provides an in-depth guide to implementing Computer Software Assurance (CSA) for GxP-regulated systems.
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.
In the early 2000s, FDA recognized they could not inspect every computer system at every regulated company and placed the onus on industry to begin assessing all regulated computer systems based on risk. The level of potential risk, should the system fail to operate properly, needed to be the basis for each company’s approach to developing a validation approach and rationale as part of the planning process. System size, complexity, business criticality, GAMP®5 category and risk rating are the five key components for determining the scope and robustness of testing required to ensure data integrity and product safety.
Until recently, the traditional approach to Computer System Validation (CSV) was believed to be required by FDA. It was also believed that following GAMP®5 practices was also a requirement. While FDA will tell industry WHAT is required, they have never dictated HOW those requirements should be met. Each company that is FDA-regulated must use critical thinking, as described in the CSA approach to come up with the most practical and innovative way to adhere to the regulations. They still must meet WHAT FDA requires, but HOW must be evaluated and determined in order to comply.
GAMP®5, Second Edition aligns well with CSA, and the two used in concert can provide a more effective and efficient means of reaching compliance for computer systems used in regulated processes.
Why Should You Attend
This Seminar is intended for those involved in planning, execution and support of computer system validation activities, working in the FDA-regulated industries, including pharmaceutical, medical device, biologics, tobacco and tobacco-related products (e-liquids, e-cigarettes, pouch tobacco, cigars, etc.).
Attendees will learn how to adapt their current method of validating FDA-regulated computer systems to align with both GAMP®5, Second Edition, published in July 2022, and CSA, a new approach that is subject of a Draft guidance from FDA that was issued in September 2022. These two guidances will reshape the way companies handle validation of computer systems that are based on newer and more innovative technologies.
Rather than avoiding these modern breakthroughs in technology and continuing to rely on older ways of conducting business, attendees will learn how to adapt their current practices and thinking about validation to leverage these innovative tools and advance their ability to bring their companies to a new level of success. Newer technologies will help them bring more advanced products to the marketplace and this can be achieved by learning how to approach validation to continue meeting FDA compliance. These include cloud-based services, Software-as-a-Service (SaaS) solutions, and software that incorporates Artificial Intelligence (AI), Machine Learning (ML) and Large Language Models (LLMs), such as ChatGPT.
✅ Course Agenda – Implementing CSA for GxP Systems
Day 1 – Foundations & Transition
- Identifying GxP systems in your organization
- Overview of traditional Computer System Validation (CSV) based on FDA requirements
- Introduction to the System Development Life Cycle (SDLC) approach
- Understanding the FDA draft guidance on Computer Software Assurance (CSA) and differences from CSV
- How GAMP®5, 2nd Edition aligns with CSA and impacts validation work
- Assessing system size, complexity, business criticality, and risk to develop a comprehensive validation rationale
- Conducting a risk assessment to support your validation strategy
- Ensuring risk-based testing of system requirements
- Preparing a Requirements Traceability Matrix (RTM) as evidence that all requirements are tested
Day 2 – Compliance, Documentation & Post-Transition Practices
- Maintaining systems in a validated state across the entire life cycle
- Ensuring data integrity with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original/True Copy, Accurate, Complete, Consistent, Enduring, Available)
- Key components of 21 CFR Part 11 compliance for electronic records and signatures
- Validating COTS, cloud-based, and SaaS solutions
- Best practices for GxP documentation and maintaining compliance with FDA requirements
- Documenting CSV efforts: requirements, design, development, testing, and operational maintenance
- Training requirements to support validation efforts
- Incorporating Organizational Change Management (OCM) to enhance adoption of new technologies
- Policies and procedures to support ongoing system validation
- Performing vendor audits to ensure proper oversight
- Preparing for FDA inspections or audits of GxP computer systems
- Understanding regulatory influences, current FDA thinking, and trends in compliance and enforcement
- Implementing industry best practices to optimize validation, maintain compliance, and ensure data integrity throughout the data lifecycle
Interactive Session:
- Q&A with expert instructors to address real-world challenges
✅ Who Will Benefit
This course is ideal for professionals involved in GxP systems implementation, compliance, and validation, including:
- Information Technology Analysts, Developers, and Testers
- Software Quality Assurance Professionals
- QC/QA Managers and Analysts
- Analytical Chemists
- Compliance and Audit Managers
- Laboratory Managers
- Automation Analysts
- Manufacturing and Supply Chain Specialists/Managers
- Regulatory Affairs and Regulatory Submissions Specialists
- Risk Management Professionals
- Clinical Data Analysts, Managers, and Trial Sponsors
- Computer System Validation Specialists
- GMP Training Specialists
- Business Stakeholders / Subject Matter Experts
- Business System / Application Testers
- Vendors and Consultants involved in software development, testing, maintenance, and validation within the life sciences industry
✅ Frequently Asked Questions (FAQ)
1. Who should attend this course?
This course is designed for professionals involved in GxP-regulated systems, including IT analysts, developers, QA/QC managers, regulatory affairs specialists, clinical data managers, business stakeholders, and vendors or consultants in the life sciences industry.
2. What are the key benefits of attending?
Participants will learn how to implement CSA for GxP systems, transition from traditional CSV approaches, develop compliant documentation, perform risk-based validation, maintain validated systems, and prepare for FDA inspections.
3. How is the course delivered?
This is a 2-day online interactive course, combining expert-led presentations, real-world case studies, and interactive Q&A sessions.
4. Will I receive a certificate?
Yes. All participants will receive a Certificate of Completion upon attending the full course, suitable for professional and training records.
5. Are any prerequisites required?
No formal prerequisites are required. However, a basic understanding of GxP systems, validation, and regulatory compliance will help participants get the most value from the course.
6. Will course materials be provided?
Yes. Each participant receives downloadable presentation slides, handouts, and supporting resources to aid learning and future reference.
Faculty Carolyn Troiano
Consulting/Training in FDA Compliance for Validation, 21 CFR Part 11 (Electronic Records/Signatures) and Data Integrity
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.
