Transition from Computer System Validation (CSV) to Computer Software Assurance (CSA)

The life science industries, including pharmaceutical, medical device, biotechnology, biological, and tobacco and tobacco-related products continue to embrace new technology to improve delivery of quality products in compliance with FDA. In addition, we’ve seen a trend toward making use of cloud services, Software-as-a-Service (SaaS) solutions, and other technical innovations such as use of Artificial Intelligence (AI), Machine Learning (ML) and Large Language Models (LLMs), such as ChatGPT that have more recently begun to be used more heavily in life science companies.

Why You Should Attend:

Providing safe and effective medical devices, drugs, and other FDA-regulated products is in the best interests of all those involved in the development, manufacturing, testing, and distribution of these products. You will learn about projects going on in industry and at FDA that take advantage of newer technologies and innovations.

In this webinar, you will learn just how to transition your validation work from classic Computer System Validation (CSV) to Computer Software Assurance (CSA), based on the 2022 draft guidance from FDA. You can increase efficiency and effectiveness of software development life cycle (SDLC) activities, enabling the delivery and support of computer solutions and new innovative products that will drive industry over the coming years.

This webinar is intended for those working in the FDA-regulated industries, including pharmaceutical, medical device, biological, animal health and tobacco. Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, adverse events management and post-marketing surveillance.

You should attend this webinar if you are responsible for planning, executing or managing the development, implementation or validation of any system governed by FDA regulations, or if you are maintaining or supporting such a system. Learn by reviewing industry best practices and knowing where to gather key information to help you move forward with these technologies quickly and in compliance with FDA.

About the Instructor

Carolyn Troiano

EAS Consulting Group, Independent Consultant

 Carolyn Troiano has more than 40 years of experience in computer system validation in the pharmaceutical, medical device, biotechnology, biologics, animal health, tobacco, e-cigarette/e-liquid and other FDA-regulated industries.

During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe, developing validation programs and strategies. She collaborated with FDA and other industry representatives on development of 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation.

Carolyn provides consulting and training on related topics to the FDA-regulated industries, ensuring content delivered and assistance provided is based on current trends in FDA compliance and enforcement, as well as industry best practices. These include FDA’s draft guidance for Computer Software Assurance (CSA) and ISPE’s GAMP®5, 2^nd Edition,. In addition, Carolyn continues researching and updating her material based on regulatory frameworks FDA is developing for industry use of AI, ML, and LLMs, such as ChatGPT in the development, manufacturing and testing of regulated products.