Live Webinar Organizational Change Management Best Practices for Computer System Validation in Industries Regulated by FDA

12:00 PM EDT | 09:00 AM PDT | 11:00 AM CDT Duration 90 Minute

Webinar Includes : All the training handouts , Certificate by the Speaker ,Q/A and 90 Min Live Webinar

"Hear By 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"

Organizational change management is a key aspect of computer system activities involving the FDA’s guidelines on the system development life cycle (SDLC).

Description

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.

Areas Covered

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 will Benefit

•     Information technology managers and analysts
•     Production managers and analysts
•     QC/QA managers and analysts
•     Clinical data managers and scientists
•     Compliance managers
•     Lab managers and staff
•     Automation analysts
•     Computer system validation specialists
•     GMP training specialists
•     Business stakeholders and individuals who are responsible for computer system validation planning, execution, reporting, compliance, training and audit
•     Consultants working in the life sciences, tobacco and related industries who are involved in computer system implementation, validation and compliance

Industries who can attend

This 90-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.


Speaker Profile

Carolyn Troiano

Carolyn Troiano has more than 35 years of experience in computer system validation in the pharmaceutical, medical device, animal health and other FDA-regulated industries. She is currently managing a large, complex data migration, analytics and reporting program at a major financial institution.

During her career, Carolyn worked directly, or as a consultant, for many top-tier pharmaceutical companies in the US and Europe. She was responsible for computer system validation across all GxP functions at a major pharmaceutical company. Carolyn developed validation programs and strategies back in the mid-1980s, when FDA guidelines were first issued. She was an industry reviewer for 21 CFR Part 11, the FDA’s electronic record/electronic signature (ER/ES) regulation. She has taught ER/ES compliance, along with computer system validation and risk management/compliance at a number of Fortune 100 firms. Her experience includes work with FDA-regulated systems used in all areas of research, development, manufacturing, quality testing and distribution.

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