Post-CSA Transition - Key Challenges and Leveraging Opportunities

So, you’ve transitioned to CSA, now what? This webinar is designed to address the critical next steps for organizations that have recently transitioned to Computer Software Assurance (CSA) in the FDA-regulated pharmaceutical, biotechnology, clinical, and medical device industries. As companies move from traditional validation approaches to CSA, they encounter a new set of challenges and opportunities. Our expert speaker will provide in-depth technical knowledge on navigating this transition effectively, ensuring compliance while leveraging the benefits of CSA.

During this webinar, we will explore the key technical challenges that organizations face post-transition, such as integrating CSA with existing quality management systems, ensuring data integrity, and maintaining robust documentation practices. We will discuss strategies to overcome these challenges, including the use of risk assessment tools, automation of validation processes, and the implementation of continuous monitoring systems. Additionally, we will highlight the opportunities CSA presents for improving software quality, reducing validation costs, and enhancing overall compliance. Participants will gain practical insights into implementing CSA best practices, understanding regulatory expectations, and optimizing their processes to achieve greater efficiency and effectiveness. Tips on how to communicate with FDA inspectors about your CSA approach, and how to document your CSA processes to withstand regulatory scrutiny, will also be covered.

WHY YOU SHOULD ATTEND:

Attending this webinar is crucial for professionals in FDA-regulated industries who are responsible for software validation and compliance. Transitioning to CSA offers significant advantages, but it also introduces complexities that must be managed effectively. By attending, you will learn how to navigate the common challenges faced after transitioning to CSA and how to leverage the opportunities it presents for enhancing software assurance and improving compliance processes. You will gain a deep understanding of the FDA’s expectations for CSA and discover strategies to reduce validation costs by focusing on critical quality attributes and risk-based approaches. This webinar will also show you how CSA can improve software quality by prioritizing assurance activities based on risk, optimizing your validation processes to achieve greater efficiency and effectiveness. You will access practical guidance and best practices for implementing CSA in your organization, benefit from the expertise of our speaker who will provide valuable insights and actionable recommendations, and participate in an interactive Q&A session to get your specific questions answered by the expert. This will prepare your organization for future regulatory changes and ensure continuous improvement in software assurance.

AREAS COVERED IN THE SESSION:

• Identifying “GxP” Systems
• Current state of CSV approach based on FDA requirements
• Agile approach to System Development Life Cycle (SDLC)
• CSA and its significance in FDA-regulated industries.
• Regulatory expectations and compliance requirements for CSA.
• How to effectively integrate CSA with existing QMS
• Common challenges faced after transitioning to CSA.
• Strategies to overcome post-transition challenges.
• Risk Assessment tools for identifying and prioritizing validation activities.
• Best practices for automating validation processes.
• Implementing continuous monitoring systems for compliance and data integrity.
• Practical documentation practices to meet regulatory requirements.
• Communicating your CSA approach to FDA inspectors.
• Case studies and examples of successful CSA transitions.
• Interactive Q&A session

WHO SHOULD ATTEND:

IT, QA, & Business Managers and Professionals who need to:

• Manage or participate on computer system projects requiring validation
• Create or approve CSV project deliverables, such as requirements documents, validation protocols (IQ, OQ, PQ), Test Plans, and Test Reports.
• Understand the process of computer system validation
• Author, implement, or upgrade CSV policies and procedures that utilize a risk-based approach to meeting the latest regulatory expectations
• Understand the FDA and international regulatory landscape around CSV

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.). Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, sample labeling, adverse events management and post-marketing surveillance.

Examples of who will benefit from this seminar include:

• 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

This seminar will also benefit any vendors and 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.