Organizational Change Management for FDA Regulated Computer Systems

This course is intended to provide specific guidelines for coaching attendees on the 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 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. 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.

Why You Should Attend:

You should attend this seminar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations, or if you are maintaining or supporting such a system as changes are made.

Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization. During the past 30 years, best practices that have been developed will ensure that the changes that will impact the organization will be identified clearly and will be minimized to eliminate additional cost and wasted time.

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 of methods, techniques and tools available.

Areas Covered in the Session : 

• Gain an understanding of the various factors that impact organizations when implementing new or updated computers
• Discuss the best practices necessary to identify challenges and concerns to minimize impact
• Learn how to communicate effectively to reduce the potential for sabotage, erection of barriers to change, and other means of canceling out the positive effect of the intended change
• Understand that each user or manager may perceive different challenges to their daily work and may begin to feel insecure about their position in the organization
• Discuss the importance of communicating early and often to assure the organization their opinions and concerns are being addressed satisfactorily
• Learn how to differentiate between “real” and “perceived” issues to eliminate the “boogey-man” and focus on real, tangible changes
• Learn how to leverage these practices to employ them during any process change experienced by the organization
• Understand the additional training that must be provided to business and IT staff involved in the change process
• Discuss the communications necessary to ensure that users are employing the appropriate changes to processes vs. using “shadow systems,” in which case they may end up duplicating work and continuing to introduce human error into the mix

Who Should Attend:

• Information Technology Departments
• Quality Assurance Departments
• Quality Control Departments
• Clinical data managers and scientists
• Compliance Departments
• Lab managers
• Automation analysts
• Computer system validation specialists
• GMP training specialists
• Business stakeholders and individuals who are responsible for computer system validation planning, execution, reporting, compliance, and audit
• Consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance

Course Director: 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. During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation. Carolyn has participated in industry conferences. She is currently active in the PMI, AITP, and RichTech, and volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.