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. Disaster recovery activities often include efforts to deal with both system functionality and data integrity, quality, accessibility and accuracy. Business continuity activities often include efforts to deal with system functionality and data integrity, quality, accessibility and accuracy, but the focus is on getting the business processes running in the absence of a sound system or data. The specific tasks and deliverables for both disaster recovery and business continuity must be completed with care toward maintaining a compliant environment. There are best practices used in the FDA-regulated arena, and these can be leveraged to develop a standard and consistent approach within a company.
The attendee will also learn how to develop a standard approach to planning, executing and documenting efforts that involve the recovery of day-to-day business operations and data in a manner that complies with FDA guidelines. Some people may be new to the concept of validation and FDA regulation and will have to be coached on how to follow any necessary procedures required for compliance. This is often true for IT staff and is likely to be the case in companies in the Tobacco industry, where regulations are emerging. It’s important to look at 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 when managing activities related to handling data.
Carolyn Troiano has more than 30 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.