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Developing a Strategic Approach to FDA Compliance for Computer System Valid

26468 E Walker Dr, Aurora, Colorado 80016-6104
26468 E Walker Dr, Aurora, Colorado 80016-6104 Aurora, CO 80016  
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Start:   Tuesday, July 10, 2018  3:00 PM
End:   Tuesday, July 10, 2018  4:30 PM

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Event Features: Business-Related, Health / Wellness

Neighborhood: Avenue of the Arts


       



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https://goo.gl/RDj86k


OVERVIEW 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. It also ensures that a system is maintained in a validated state throughout its entire life cycle, from conception through retirement. We will discuss the phases within the SDLC, and how these form the basis for any CSV project.
WHY SHOULD YOU ATTEND
An FDA inspection or audit is something to take very seriously, and it’s important to have all computer systems that are regulated by FDA fully validated. In this webinar, you will learn how to validate computer systems in compliance with FDA’s guidelines and also how to maintain them in a validated state.
AREAS COVERED
• Computer System Validation (CSV) and the System Development Life Cycle (SDLC) Methodology
• Good “Variable” Practice (GxP) (Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP))
• Validation Strategy that will take into account the system risk assessment process
• Functional Requirements Specification (FRS) to include detailed needs that are described in a specific and unique way
• System Design Specification (SDS) that link design to functional requirements
LEARNING OBJECTIVES
• Learn about industry best practices related to compliance and computer system validation
• Learn about strategies for reducing the cost and complexity of compliance with FDA regulations
• Understand how the System Development Life Cycle (SDLC) methodology supports the computer system validation process
• Learn how to develop the appropriate computer validation strategy, to ensure a good balance of cost vs. risk, thus minimizing both
WHO WILL BENEFIT
• Information Technology Analysts
• QC/QA Managers
• QC/QA Analysts
• Clinical Data Managers
• Clinical Data Scientists
• Analytical Chemists
• Compliance Managers
• Laboratory Managers
All FDA-regulated industries:
• Pharmaceutical
• Biologicals
• Medical Device
• Tobacco

For more detail please click on this below link:
https://goo.gl/vF6ZG7


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Tel: +1-720-996-1616
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