Implementing CSA for GxP Systems - Transition, Documentation, and Post-Transition Challenges and Opportunities

• Fundamentals of GxP systems and their compliance requirements
• FDA’s CSA approach versus traditional CSV methodologies
• Agile and Waterfall methodologies for system development and validation
• Integrating CSA principles into quality management systems
• Risk-based validation strategies for compliance and data integrity
• Effective documentation practices for CSA implementation
• Continuous validation techniques and automated testing tools
• Transition challenges and solutions for adopting CSA
• Post-transition strategies for maintaining compliance and assurance
• Vendor audits and supplier assessments in CSA contexts
• Implementing CSA for cloud-based, SaaS, and COTS systems
• Policies and procedures to support CSA adoption
• Addressing data integrity concerns through CSA principles
• Preparing for FDA inspections and communicating CSA strategies
• Case studies highlighting successful CSA transitions
• Leveraging CSA to reduce costs and enhance software quality
• Continuous monitoring systems for regulatory compliance
• Aligning CSA initiatives with organizational goals

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.

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

DAY 2 (10 AM to 3 PM)

• 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

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.