The transition to Computer Software Assurance (CSA) marks a pivotal shift in the approach to compliance for FDA-regulated industries. This two-day seminar is designed to guide professionals in understanding the strategic and technical aspects of CSA implementation. With a focus on transitioning from the traditional Computer System Validation (CSV) methodology, the seminar covers risk-based validation, iterative approaches like Agile, and the integration of CSA principles into quality management systems (QMS).
Participants will explore how CSA enhances compliance by prioritizing critical thinking, risk-based assessments, and automation. The seminar delves into documentation strategies, continuous validation techniques, and overcoming post-transition challenges such as data integrity and regulatory communication. Attendees will also gain insights into leveraging CSA opportunities to optimize software quality, reduce validation costs, and ensure alignment with FDA’s expectations.
Participants will explore how CSA enhances compliance by prioritizing critical thinking, risk-based assessments, and automation. The seminar delves into documentation strategies, continuous validation techniques, and overcoming post-transition challenges such as data integrity and regulatory communication. Attendees will also gain insights into leveraging CSA opportunities to optimize software quality, reduce validation costs, and ensure alignment with FDA’s expectations.
Why You Should Attend:
This seminar is a must-attend for professionals aiming to master CSA implementation for GxP systems. Transitioning to CSA offers transformative benefits, but it demands a clear understanding of regulatory expectations, risk-based strategies, and effective documentation. You will gain expert insights into overcoming common challenges, ensuring data integrity, and integrating CSA into your quality systems.Course Content
DAY 1 (10 AM to 3 PM)- Introduction to GxP systems and FDA’s CSA framework
- Comparison of CSA and traditional CSV methodologies
- Exploring Agile and Waterfall approaches for validation
- Fundamentals of risk-based validation and its applications
- Documentation strategies for transitioning to CSA
- CSA implementation for cloud-based and SaaS systems
- Policies and procedures to support effective CSA adoption
- Interactive Q&A session
- Identifying and addressing post-transition challenges
- Continuous validation and automated testing for CSA
- Risk assessments and prioritization strategies
- Ensuring data integrity through CSA practices
- Vendor audits and IT supplier assessments for CSA compliance
- Preparing for FDA inspections and communicating CSA approaches
- Case studies and practical examples of CSA success
- Interactive Q&A session
Speaker
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.
Who Should Attend
- Information Technology Analysts
- Information Technology Developers and Testers
- QC/QA Managers and Analysts
- Analytical Chemists
- Compliance and Audit Managers
- Laboratory Managers
- Automation Analysts
- Manufacturing Specialists and Managers
- Supply Chain Specialists and Managers
- Regulatory Affairs Specialists
- Regulatory Submissions Specialists
- Clinical Data Analysts
- Clinical Data Managers
- Clinical Trial Sponsors
- Computer System Validation Specialists
- GMP Training Specialists
- Business Stakeholders/Subject Matter Experts
- Business System/Application Testers
- Consultants working in the life sciences industry
