Business Process Re-engineering and FDA-Regulated Computer System Projects

Duration: 60 Minutes
This course will describe how to incorporate business process re-engineering into a project that includes a GxP (Good Manufacturing Practices, Good Laboratory Practices or Good Clinical Practices) system, meaning one that is regulated by the FDA. We will review the strategy and tactical approach for ensuring the maximum business benefits and achieving FDA compliance.
FDA Compliance
Instructor: Carolyn Troiano
Product ID: 500806

Most companies search for ways to improve their operational processes in order to gain efficiencies or provide more effective ways of conducting business. These processes generally are part of a computer system or application that has specific functionality. As such, the computer system will need to be validated if it is operating in an FDA-regulated environment under Good Manufacturing, Good Laboratory or Good Clinical practices. Once a process is changed, the computer system will require some changes, and these will have to be in accordance with FDA's requirements for computer system validation, including change control. There are specific best practices that will enable you to determine the cost/benefit of making such changes, and the steps that will lead to lowering that cost while improving compliance.

Why Should you Attend:
This course will provide you with an understanding of how to assess the potential for improving the efficiency and effectiveness of a process that supports a computer system in a GxP environment. You will learn the key factors in making a decision to improve the process, and the steps required to ensure that the computer system remains in a validated state and in compliance with FDA.

Objectives of the Presentation:
The webinar will cover:
  • Basic review of GxP systems and validation requirements
  • System Development Life Cycle (SDLC) methodology and how to incorporate business process reengineering into it
  • Basic review of the SDLC and phases affected by reengineering
  • Identification of the validation components that must be revisited as a result of business process reengineering
  • Overview of cost/benefit vs. compliance when approaching the topic of business process reengineering
  • Review of industry best practices and potential pitfalls to avoid
  • Case study in improving a system through reengineering, while ensuring it remains in a validated state
  • Recap and Q&A
Who can Benefit:
This course should be attended by those engaged in the development, implementation, testing, maintenance or use of a computer system regulated by FDA. In particular, this course will be of interest to those who are adept at understanding the business processes underlying their computer systems and have a desire to improve these to gain greater efficiency and effectiveness in operations.

$375
Recorded Session for one participant
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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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