Developing a Strategic Approach to FDA Compliance for Computer Systems

Why Should You Attend:

Effective and compliant computer system validation is critical to any FDA-regulated organization. During the past 30 years, best practices have been developed and, if followed, can ensure laboratory computer systems are validated efficiently and in compliance with FDA regulations. This webinar will provide guidance for planning, executing and validating a laboratory computer system, and managing the system in a validated state through the end of the system life cycle.

The webinar will take you through the validation process, indicating key aspects of the approach, including GAMP 5 System Classification, Risk Assessment and overall development of a sound validation strategy. We will cover the actual validation phases, deliverables and key points to ensuring the work is in accordance with FDA requirements for computer system validation, while also making sure the approach is cost effective for your organization.

The webinar will also address roles and responsibilities, timing of phases and deliverables, business process reengineering, organizational change management, change control and audit trails, training and documentation. You will learn what is required not only to validate your laboratory system, but maintain it in a validated state until it is retired or otherwise no longer in use. There is an enormous body of documentation and information available on computer system validation, which can be overwhelming. This course will provide a condensed overview of the practices that deliver the best results by directing the attendees to the most critical and cost-effective of methods, techniques and tools available.

Areas Covered in the Webinar:

• System Development Life Cycle (SDLC) Methodology
• Computer System Validation (CSV)
• Good “Variable” Practice (GxP)
• Good Manufacturing Practice (GMP)
• Good Laboratory Practice (GLP)
• GAMP 5 Guidance for System Classification
• Risk Assessment and Management
• Validation Strategy
• Change Control and Audit Trails
• User Requirements Specification (URS) & Functional Requirements Specification (FRS)
• System Design Specification (SDS) and System Configuration Specification (SCS)
• Test Planning, Execution and Documentation (IQ/OQ/PQ)
• Requirements Traceability Matrix (RTM)
• System Acceptance, Release Notification and Deployment
• System Retirement
• Data Governance Archival
• Q&A

Free Materials:

During the webinar we will discuss FDA Guidance Documents and GAMP5, the Good Automated Manufacturing Practices. There will also be an overview of Policies and Procedures, including a checklist of topics.

Who Will Benefit:

• Information Technology Analysts
• QC/QA Managers
• QC/QA Analysts
• Clinical Data Managers
• Clinical Data Scientists
• Analytical Chemists
• Compliance Managers
• Laboratory Managers
• Automation Analysts
• Manufacturing Managers
• Manufacturing Supervisors
• Supply Chain Specialists
• Computer System Validation Specialists
• GMP Training Specialists
• Business Stakeholders responsible for computer system validation planning, execution, reporting, compliance, maintenance and audit
• Consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance
• Auditors engaged in the internal inspection of labeling records and practices

Carolyn Troiano
ERP Project Manager, City of Richmond

Carolyn Troiano has more than 35 years of experience in computer system validation and compliance in the pharmaceutical, medical device, 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.

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