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Speaker : Carolyn TroianoCarolyn Troiano has more than 25 years of experience in computer system validation inthe pharmaceutical, medical device, animal health and other FDA-regulated industries. Sheis currently the ERP (Enterprise Resource Planning) Program Manager at the City ofRichmond, VA, where she is overseeing the implementation of a large, complex systemthat spans more than 40 agencies and is used by more than 4,000 City employees. Carolynalso headed up the IT risk management program at Philip Morris USA, at a time in the mid-2000’s when the company was steering toward a new strategy that includedpharmaceutical entities. She provided the groundwork for the standards that would benecessary as the FDA began to regulate tobacco products. Carolyn has participated inindustry conferences, providing very creative and interactive presentations. She iscurrently active in the Project Management Institute (PMI), Association of InformationTechnology Professionals (AITP), and Oracle User Group chapters in the Richmond, VAarea. Carolyn also volunteers for the PMI’s Educational Fund as a project managementinstructor for non-profit organizations.

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How to approach organizational change management whenautomating processes that require FDA compliance

Course Description:We will discuss the importance of applying industry best practices for organizational changemanagement as they relate to the planning, execution and validation of systems to complywith FDA requirements. Most system implementation and upgrade efforts involve change, ascompanies strive to improve their business processes to achieve greater efficiency andeffectiveness. To effect this change, the team must be ready to anticipate and address thechallenges that will be faced from users and others engaged in the project who are not soinclined 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 andinformation. If processes change such that users who had a part in the review and approval ofdata and/or information are no longer required to participate, they may feel insecure, bothabout how well data integrity, identity and accuracy is maintained, and about their own jobstability. It is not uncommon for newer systems to take over the role of automatic matchingor checking that was once done by a human. Once thoroughly tested, the process eliminatesthe 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 whichthey must participate in any validation effort. IT resources that are not typically involved inFDA-regulated systems may not have the training required to provide implementation ormaintenance support. It is critical that if they are involved, they buy into the concept that they

Topic ID : 489 Duration : 60 Mins

Attend Live Webinar17-Sep-2014 : 10:00 AM PST

$ 229.00 Single Attendee $ 749.00 Group – Max 10 Attendees perlocation (For multiple locations contact Customer Care)

$ 269.00 Access Recorded Version online Available for one viewer for 6 Months (For multiple viewers, please contact Customer Care)Recorded Link and Reference material will beavailable in My Account Section, 48 hrs aftercompletion of Live training

$ 399.00 Buy Training CD-DVD CD-DVD is meant for single location use.(For multiple locations, please contact Customer Care)Recorded CD-DVD will be despatched after 72 hrs oncompletion of Live training

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maintenance support. It is critical that if they are involved, they buy into the concept that theymust 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 intodata/information, or if their data/information is now visible to others who previously could notsee it, they will have some concerns. They must have a thorough understanding of the levelof 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 thisinformation 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 maintainedthrough reporting, and the reports are in real-time, meaning they are always up-to-date. If thisis 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 allayany concerns they may have about the future. Identifying these is critical to avoid complaintsand non-compliance later on. In extreme cases, there could be sabotage, which could sidelineany effort quickly and destroy the credibility of the teamCourse Objective:You should attend this seminar if you are responsible for planning, executing or managing theimplementation of any system governed by FDA regulations, or if you are maintaining orsupporting 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 willensure that the changes that will impact the organization will be identified clearly and will beminimized to eliminate additional cost and wasted time.

There is an enormous body of documentation and information available that can beoverwhelming. This course will provide a condensed overview of the practices that deliver thebest 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 whenimplementing new or updated computersDiscuss the best practices necessary to identify challenges and concerns to minimizeimpactLearn how to communicate effectively to reduce the potential for sabotage, erection ofbarriers to change, and other means of canceling out the positive effect of the intendedchangeUnderstand that each user or manager may perceive different challenges to their dailywork and may begin to feel insecure about their position in the organizationDiscuss the importance of communicating early and often to assure the organizationtheir opinions and concerns are being addressed satisfactorilyLearn how to differentiate between “real” and “perceived” issues in order to eliminatethe “boogey-man” and focus on real, tangible changesLearn how to leverage these practices to employ them during any process changeexperienced by the organizationUnderstand the additional training that must be provided to business and IT staffinvolved in the change processDiscuss the communications necessary to ensure that users are employing the

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Discuss the communications necessary to ensure that users are employing theappropriate changes to processes vs. using “shadow systems,” in which case they mayend up duplicating work and continuing to introduce human error into the mixQ&A

Learning Objectives:

Upon completion of this session, attendees will have an understanding of how to managechange during computer system validation planning, execution and maintenance. They willhave received the guidance on best practices necessary to identify user concerns andanticipate challenges. They will understand the steps for effecting change across theorganization in a positive and cost-effective manner. The attendees will have a good grasp ofhow to leverage these practices across all systems by creating a standardized program fororganizational 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 systemvalidation planning, execution, reporting, compliance, and audit.

This webinar will also benefit any consultants working in the life sciences industry who areinvolved in computer system implementation, validation and compliance.

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