Organizational Change Management (OCM) Best Practices for Computer Systems Regulated by FDA


Carolyn Troiano is Keynote Speaker at ComplianceKey.She has more than 30 years of experience during which she worked directly, or as a consultant, for many top-tier pharmaceutical, medical device and biological companies in the US and Europe. She was responsible for computer system validation compliance activities across all GxP functions at a major pharmaceutical company. She developed computer system validation programs and strategies and was an industry reviewer for 21 CFR Part 11, the FDA's electronic record/electronic signature (ER/ES) regulation. Carolyn has participated in industry conf........

Overview

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.

Why should you attend this webinar?

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.

Areas Covered in the Session:

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:

You should attend this webinar 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. Examples of who will benefit from this webinar include:

This webinar will also benefit any consultants working in the life sciences and tobacco-related industries who are involved in computer system implementation, validation and compliance.



Webinar Id: LSHCCT002

Training Options:

Duration: 90 mins

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 Recorded: [Six month unlimited access]

 $167 (Single Attendee)  $599 (Unlimited Attendee)

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