21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

This webcast will help You understand in detail the application of FDAs 21 CFR Part 11 guidance on electronic records/electronic signatures (ER/ES) for computer systems subject to FDA regulations. This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do. It also ensures that a system is maintained in a validated state throughout its entire life cycle, from conception through retirement.

ER/ES capability can vary, and the approach should be based on the specific case and the risk of failing to meet the guidance associated with it.

You should attend this webinar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations that uses ER/ES capability, or if you are maintaining or supporting such a system.

Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization. During the past 30 years, best practices that have been developed will ensure that validation activities are cost-effective while meeting all aspects of FDA compliance.

There is an enormous body of documentation and information available that can be overwhelming. This course will provide a condensed overview of the key practices that deliver the best results by directing the attendees to the most critical and cost-effective methods, techniques and tools available.

• GxP systems regulated by FDA
• Computer System Validation (CSV) methodology
• System Development Life Cycle (SDLC) framework
• 21 CFR Part 11 guidance for electronic records/signatures (ER/ES)
• Cost-benefit and rationale for implementing ER/ES
• Security and Access
• User roles and profiles
• Workflow and approvals
• Document tracking
• Risk and mitigation associated with ER/ES
• Organizational change management for users
• Potential pitfalls for ER/ES implementation
• ER/ES best industry practices with examples

• Gain an understanding of FDAs 21 CFR Part 11 Electronic Records/Electronic Signatures (ER/ES) guidance document
• Develop the ability to apply 21 CFR Part 11 when implementing, validating and maintaining computer systems in your organization
• Understand the best practices for maintaining a computer system with ER/ES capability in a validated state
• Understand some of the key ?pitfalls? to avoid when employing ER/ES capability and learn more.

• Information Technology Analysts
• Information Technology Developers and Testers
• QC/QA Managers and Analysts
• Clinical Data Managers and Scientists
• Analytical Chemists
• Laboratory Managers
• Automation Analysts
• Computer System Validation Specialists
• GMP Training Specialists
• Business Stakeholders/Subject Matter Experts
• Business System/Application Testers