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Live Webinar on Functional System Requirement Computer Systems Regulation

26468 E Walker Dr, Aurora, Colorado 80016-6104
26468 E Walker Dr, Aurora, Colorado 80016-6104 Aurora, CO 80016  
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Start:   Wednesday, March 13, 2019  1:00 PM
End:   Wednesday, March 13, 2019  2:30 PM

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Event Features: Health / Wellness

Neighborhood: Avenue of the Arts


       



https://bit.ly/2RFDgUG


OVERVIEW This webinar will take you through the System Development Life Cycle (SDLC) approach to Computer System Validation (CSV), focusing on the definition, testing, and documentation of functional and other requirements to ensure the system meets FDA compliance.
This FDA compliance training will help you understand how the definition of functional and other system requirements fit into the System Development Life Cycle (SDLC) approach to Computer System Validation (CSV). Getting the requirements right, and ensuring they are comprehensive, is one of the most challenging components of the process.
WHY SHOULD YOU ATTEND
You should attend this webinar to learn about:
• Computer System Validation (CSV) approach.
• Using the System Development Life Cycle (SDLC) methodology to support CSV efforts.
• CSV and SDLC deliverables that must be documented properly to comply with FDA requirements.
• A deeper dive into the Functional Requirements Specification (FRS) deliverable, a key document to support the CSV effort.
AREAS COVERED
• Requirements for Computer System Validation (CSV) in compliance with FDA.
• Applying a strategic approach to CSV for FDA compliance.
• Using the System Development Life Cycle (SDLC) methodology to support CSV.
• CSV strategic planning, execution, and documentation.
• Detailed analysis of the Functional Requirements Specification (FRS), a key deliverable for the CSV effort.
LEARNING OBJECTIVES
• We will provide an overview of FDA’s guidelines as they pertain to computer system validation of GxP systems used in manufacturing, marketing, distribution and other operational activities engaged by companies in FDA-regulated industries.
WHO WILL BENEFIT
This webinar will provide valuable assistance to all personnel in:
• Data “Owners”
• Data “Stewards”
• Information Technology Analysts
• Information Technology Developers and Testers
• QC/QA Managers and Analysts
• Clinical Data Managers and Scientists
• Analytical Chemists
• Compliance and Audit Managers
• Laboratory Managers
• Automation Analysts
For more detail please click on this below link:
https://bit.ly/2Bn14r8
Email: support@trainingdoyens.com
Toll Free: +1-888-300-8494
Tel: +1-720-996-1616
Fax: +1-888-909-1882


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