Last Chance to Register Live Webinar -Risk-Based Approach to CSV, 21 CFR Part 11 and FDA Compliance

Live Webinar: Risk-Based Approach to CSV, 21 CFR Part 11 and FDA Compliance When: Wednesday August 4, 2021 - 01:00 PM EDT Duration: 90 Minutes.

Register Now for Live Virtual Webinar

FDA’s recent focus on data integrity during computer system validation inspections and audits has brought this issue to the forefront of importance for compliance of systems used in regulated industries. These include all systems that “touch” product, meaning they are used to create, collect, analyze, manage, transfer and report data regulated by FDA. This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology when validating 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, and a key element is a thorough risk assessment. It also ensures that a system is maintained in a validated state throughout its entire life cycle, from conception through retirement, making it critical to continue assessing risk as changes are made. We will discuss the phases within the SDLC, and how these form the basis for any CSV project. The importance of the sequence of steps will also be covered.
Areas Covered in the Webinar:
Learn how to identify “GxP” Systems
Discuss the Computer System Validation (CSV) approach based on FDA requirements
Learn about the System Development Life Cycle (SDLC) approach to validation
Discuss the best practices for documenting computer system validation efforts, including requirements, design, development, testing and operational maintenance procedures
Understand how to maintain a system in a validated state through the system’s entire life cycle
Understand the key components of 21 CFR Part 11 compliance for electronic records and signatures
Learn how to assess risk, based on probability of occurrence, severity of impact, detectability and mitigation, along with technical and procedural controls that can help minimize risk
Learn how to best prepare for an FDA inspection or audit of a GxP computer system