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

The transition to Computer Software Assurance (CSA) marks a pivotal shift in the approach to compliance for FDA-regulated industries. This two-day seminar, "Implementing CSA for GxP Systems - Transition, Documentation, and Post-Transition Challenges and Opportunities," 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. This comprehensive program equips you with actionable knowledge and best practices to succeed in the evolving compliance landscape.

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. The program provides practical guidance on leveraging automation, reducing validation costs, and improving software assurance. Whether preparing for regulatory inspections or striving for operational excellence, this seminar will empower you to navigate CSA transitions effectively and achieve sustained compliance success.

SEMINAR OBJECTIVES

WHO SHOULD ATTEND

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.

AGENDA

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