How to Approach Organizational Change Management When Automating Processes That Require FDA Compliance

Dennis Weissman

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We will discuss the importance of applying industry best practices for organizational change management as they relate to the planning, execution and validation of systems to comply with FDA requirements.  Most system implementation and upgrade efforts involve change, as companies strive to improve their business processes to achieve greater efficiency and effectiveness.  To effect this change, the team must be ready to anticipate and address the challenges that will be faced from users and others engaged in the project who are not so inclined to want to do things differently, even if it’s for the betterment of the company.

The key challenge for many users involves their ability, or lack thereof, to control data and information.  If processes change such that users who had a part in the review and approval of data and/or information are no longer required to participate, they may feel insecure, both about how well data integrity, identity and accuracy is maintained, and about their own job stability.  It is not uncommon for newer systems to take over the role of automatic matching or checking that was once done by a human.  Once thoroughly tested, the process eliminates the potential for human error, while reducing the time and cost associated with it.

A key challenge to IT and other implementation and support personnel is the degree to which they must participate in any validation effort.  IT resources that are not typically involved in FDA-regulated systems may not have the training required to provide implementation or maintenance support.  It is critical that if they are involved, they buy into the concept that they must do this work in a compliant manner, and that there is no room for short-cuts.

Management may also erect barriers to change.  If they no longer have visibility into data/information, or if their data/information is now visible to others who previously could not see it, they will have some concerns.  They must have a thorough understanding of the level of security applied and knowledge of exactly who has what type of access to it.  In addition, while they may have received reports in the past, they may now be required to get this information directly from the system by logging in and running a query or report electronically.  They will have to be assured that the data sources are the same, the integrity is maintained through reporting, and the reports are in real-time, meaning they are always up-to-date.  If this is not the case, that also must be conveyed to them.

The goal is to communicate effectively the impact of change to users and others, and to allay any concerns they may have about the future.  Identifying these is critical to avoid complaints and non-compliance later on.  In extreme cases, there could be sabotage, which could sideline any effort quickly and destroy the credibility of the team

Course Objective

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.

Course Outline

  • 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 in order 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
  • Q&A
Learning Objectives:

Upon completion of this session, attendees will have an understanding of how to manage change during computer system validation planning, execution and maintenance.  They will have received the guidance on best practices necessary to identify user concerns and anticipate challenges.  They will understand the steps for effecting change across the organization in a positive and cost-effective manner.  The attendees will have a good grasp of how to leverage these practices across all systems by creating a standardized program for organizational change management.

Target Audience

  • Information technology analysts, 
  • QC/QA managers and analysts, 
  • Clinical data managers and scientists, 
  • Analytical chemists, 
  • Compliance managers, 
  • 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.  
This webinar will also benefit any consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance.

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Speaker: Dennis Weissman, President, Dennis Weissman and Associates LLC

Dennis Weissman is a nationally known independent analyst and thought leaders in the clinical laboratory and pathology sectors for over three decades. Dennis is president of Dennis Weissman & Associates, LLC of Falls Church, VA, a consultancy which provides market intelligence, M&A advisory services, public policy monitoring & advice and business leadership to diagnostic and life science companies and organizations. He has expertise in Medicare and health care reform policies and trends; clinical lab and pathology payment and compliance policies as well as M&A and business issues and direction to diagnostic and life science companies.

Dennis founded and served as publisher of Washington G-2 Reports (now G2 Intelligence) from 1979 through 1999, an information company that reports on and analyzes the U.S. clinical laboratory industry via newsletters, research reports; webinars and live conferences. Prior to G2, he served as Director of the Washington Office of the American Society for Medical Technology (now ASCLS) and before that, Special Assistant to the Deputy Assistance Secretary for Health, U.S. Department of Health, Education & Welfare (now HHS).

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