Organizational Change Management Practices for FDA-Regulated Computer Systems

FDA guidelines are very specific in terms of how computer systems are to be managed, and each company should have a specific strategy and methodology, along with a set of rigorous tactical processes and procedures that prescribe how organizational change should be managed.

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 deliver the best results by directing the attendees to the most critical and cost-effective techniques and tools available to assure compliance.

The attendee will learn how to develop a standard approach to managing organizational change when users not only have to accept new processes, workflows and systems, but have to do so in a manner that complies with FDA guidelines for computer systems. In some cases, users will be new to the concept of validation and FDA regulation, and will have to be coached on how to follow the necessary procedures. This is true in the Tobacco industry, where regulations are emerging, but it is also true in pharmaceutical and related industries where IT staffing may not have the skills or training required. It's important to look at what is going to change, what are some of the threats and challenges, and what methods you can use to mitigate these.

There are specific guidelines and best practices for creating organizational change as it relates to computer systems regulated by FDA.  These include, but are not limited to system implementation, testing, validation, migration, integration, upgrade and retirement.

The course will focus on the key aspects of organizational change management, including best practices and principles for handling this key component of project work 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 aspects of change management, including planning, execution, assessment and feedback.  The result will be a prescriptive approach to helping teams and individuals reach a higher level of acceptance to change.

• Information technology analysts
• QC/QA managers and analysts
• Clinical data managers and scientists
• Analytical chemists
• Compliance managers
• Lab managers,
• Automation analysts

Carolyn Troiano has more than 35 years of experience in computer system validation 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. She is currently building an FDA computer system validation compliance strategy at a vapor company. Carolyn has participated in industry conferences, and is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area. Carolyn also volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.