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Computer System Validation (CSV) for FDA-Regulated Computers

Event Details

Computer System Validation (CSV) for FDA-Regulated Computers

Time: March 28, 2019 from 10am to 11:30am
Location: Online
Street: 161 Mission Falls Lane, Suite 216,
City/Town: Fremont
Website or Map: http://www.traininng.com/webi…
Phone: 18004479407
Event Type: webinar
Organized By: Joseph Wilcox
Latest Activity: Feb 28

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Event Description

Overview

FDA requires that all computer systems used to produce, manage and report on GxP (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. This webinar will leave you with the information needed to plan, execute and document a computer system validation effort that meets FDA compliance standards.

You'll learn about the various computer system validation deliverables and how to document them through the entire process. You will learn about what must be done to ensure the system remains in a validated state. In addition, you'll learn all about how to create and maintain good FDA-compliant documentation using a strategic approach based on the System Development Life Cycle (SDLC) Methodology.

Why should you Attend

 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. The importance of the sequence of steps will also be covered.

Areas Covered in the Session

  • Computer System Validation (CSV)
  • System Development Life Cycle (SDLC) Methodology
  • Good"Variable" Practice (GxP) (Good Manufacturing
  • Practice (GMP), Good Laboratory Practice, Good Clinical Practice (GCP)
  • Validation Planning
  • GAMP 5 System Classification
  • Risk Assessment
  • Functional Requirements Specification
  • Configuration and Custom Coded Solutions
  • Installation Qualification (IQ) Testing
  • Operational Qualification (OQ) Testing
  • Performance Qualification (PQ) Testing (User Acceptance Testing/UAT
  • Validation Summary Report
  • Operational Maintenance for Validated Systems
  • Policies and Procedures
  • Training
  • Organizational Change Management (OCM)
  • Periodic System Review
  • Disaster Recovery and Business Continuity Planning
  • System Retirement

Who Will Benefit

  • Information Technology (IT) Analysts
  • IT Developers
  • IT Support Staff
  • QC/QA Managers and Analysts
  • Clinical Data Managers and Scientists
  • Compliance Managers and Auditors
  • Lab Managers and Analysts
  • Computer System Validation Specialists
  • GMP Training Specialists
  • Business Stakeholders using Computer Systems regulated by FDA
  • Regulatory Affairs Personnel
  • Consultants in the Life Sciences and Tobacco Industries
  • Interns working at the companies listed above
  • College students attending schools and studying computer system validation, regulatory affairs/matters (related to FDA) or any other discipline that involves adherence to FDA regulatory requirements

Speaker Profile

Carolyn (McKillop) Troiano has more than 35 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs. Carolyn is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area. 

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