Organizational Change Management Best Practices for Systems Regulated by FDA

MessageThis Webinar is over
Date Oct 8, 2014
Time 12:00 PM EDT
Cost $183.00
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.
Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacture, testing, distribution and management of a product in the pharmaceutical, biotechnology, medical device, animal health, tobacco and other regulated industries.

Organizational change management is a key aspect of computer system activities involving the FDA's guidelines on the system development life cycle (SDLC). As such, there are specific deliverables and tasks that must be completed in accordance with FDA requirements.

There are best practices associated with testing methodologies used in the FDA-regulated arena, and these can be used to develop a standard and consistent approach within a company.

Why Should you Attend:
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 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.

Objectives of the Presentation:
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.

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.

Who can Benefit:
Information technology analysts, project managers, organizational change managers, business process engineers, QC/QA managers and analysts, clinical data managers and scientists, analytical chemists, compliance managers, lab managers, automation analysts, computer system validation specialists, GxP training specialists, business stakeholders and individuals who are responsible for computer system validation planning, execution, testing, reporting, compliance, and audit. This webinar will also benefit any consultants, contractors or vendors providing products and services to the life sciences industries and who are involved in computer system implementation, validation and compliance.

Live Session - How it works
  • Username and Password will be sent to you 24 hours prior to the webinar
  • Presentation handouts in pdf formate will be mailed to you
  • Login to the session using the username and password provided to you
  • Get answer to your queries through interactive Q&A sessions via chat
  • Please let us know your thoughts and views at the end of webinar, your valuable feedback will help us improve
  • Get certification of attendance.
Recorded Session - How it works
  • A link will be provided to you upon purchase of the recorded session
  • Please click on the link to access the session
  • Presentation handouts in pdf formate will be mailed to you
  • Get certification of attendance.

Instructor Profile:

Carolyn Troiano has more than 25 years of experience in computer system validation in the pharmaceutical, medical device, animal health and other FDA-regulated industries. She is currently the ERP (Enterprise Resource Planning) Program Manager at the City of Richmond, VA, where she is overseeing the implementation of a large, complex system that spans more than 40 agencies and is used by more than 4,000 City employees.

Prior to working for the City, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. Carolyn was responsible for computer system validation across all regulated functions at Wyeth Laboratories, now part of Pfizer. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject. While at Wyeth, Carolyn co-authored 21 CFR Part 11, or the FDA’s electronic record/electronic signature (ER/ES) regulation as part of an FDA/Industry partnership. She has taught ER/ES compliance, along with computer system validation and risk management/compliance at a number of Fortune 100 pharmaceutical, medical device and other regulated firms. Her experience includes work with laboratory automation systems (LAS), laboratory information management systems (LIMS), clinical data systems (CDS) and many other FDA-regulated systems involved in the manufacturing, testing and distribution of pharmaceutical and biological products.

During her career, Carolyn worked with Merck as an automation analyst and with Eli Lilly as Manager of Computer System Validation for a new plant in VA. She has also done consulting work at Schering-Plough (now part of Merck), Novartis, Lederle Labs, Glaxo-Smith-Kline, Johnson & Johnson, Bristol-Myer-Squibb, Forest Labs, Aventis Behring and Aventis Pasteur, amongst many other companies, large and small.

Carolyn has participated in industry conferences, providing very creative and interactive presentations. She is currently active in the Oracle User Group, 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.

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