In-Depth Testing for Computer Systems Regulated by FDA

Duration: 60 Minutes
This course is intended to provide specific guidelines for developing an approach for in-depth testing of computer systems regulated by FDA. These include, but are not limited to system implementations, migrations, integrations, upgrades and retirement.
FDA system validation
Instructor: Carolyn Troiano
Product ID: 500496

Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacturing, testing, distribution and management of a product in the pharmaceutical, biotechnology, medical device, animal health, tobacco and other regulated industries.

Testing is a key aspect of computer system implementation, validation and all activities related to the system development life cycle (SDLC). As such, there are specific deliverables and key tasks that must be completed in accordance with FDA requirements.

The best practices associated with testing methodologies used in the FDA-regulated arena, can be used to develop a standard and consistent approach within a company.

Why Should you Attend:
The attendee will learn how to develop a standard approach to testing for all computer system efforts regulated by FDA that will be robust and will meet all compliance requirements.

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

Objectives of the Presentation:
The course will focus on the key aspects of testing, including best practices and principles for a computer system used in an FDA-regulated environment (i.e., the system "touches" product during the manufacturing, testing or distribution of the product, or during any other functional activity). The material will include the various components of testing, including planning, execution, documentation and preparing a summary report. The result will be a prescriptive approach to conducting testing of any computer system regulated by FDA.

FDA guidelines are very specific in terms of how computer systems are to be tested, and each company should have a specific strategy and methodology, along with a set of rigorous internal policies and procedures that prescribe how testing should be planned, executed and documented.

Who can Benefit:
  • Information technology analysts, project managers, organizational change managers, business process engineers, QC/QA managers and analysts, clinical data managers and scientists, analytical chemists, compliance managers, lab managers, automation analysts, computer system validation specialists, GxP training specialists, business stakeholders and individuals who are responsible for computer system validation planning, execution, testing, reporting, compliance, and audit.
  • This webinar will also benefit consultants working in the life sciences industry, who are involved in computer system implementation, validation and compliance.
Live Session - How it works
  • Username and Password will be sent to you 24 hours prior to the webinar
  • Presentation handouts in pdf formate will be mailed to you
  • Login to the session using the username and password provided to you
  • Get answer to your queries through interactive Q&A sessions via chat
  • Please let us know your thoughts and views at the end of webinar, your valuable feedback will help us improve
  • Get certification of attendance.
Recorded Session - How it works
  • A link will be provided to you upon purchase of the recorded session
  • Please click on the link to access the session
  • Presentation handouts in pdf formate will be mailed to you
  • Get certification of attendance.
$375
Recorded Session for one participant
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  $500.00 Training CD
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  $600.00 Training USB Flash Drive
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For multiple location please contact our customer care team +1-510-857-5896.
How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Carolyn Troiano has more than 35 years of experience in the pharmaceutical, medical device, tobacco 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.
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