Business Process Re-engineering and FDA-Regulated Computer System Projects
Duration : 60 Minutes
Carolyn Troiano,
Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects. Du Read more
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.
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.
Course Objectives:
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.
Course Outline:
• 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
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will 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.
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
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