This webinar will provide the best industry practices to follow when auditing a vendor of a computer system that is regulated by the FDA. We will discuss the best approach for assessing a vendor’s organization, capability, physical/logical security practices, requirements, code development/management practices, version control, change control, compliance with 21 CFR Part 11 (electronic records/electronic signatures), testing, operations management, disaster recovery, document management, and customer service. A template and checklist are provided for use in conducting vendor audits. These will help guide you through the process and ensure you fully assess the vendor’s capability.
Effective and compliant computer system development, testing, and validation are critical to any pharmaceutical or FDA-regulated organization. You should attend this seminar if you are responsible for planning, executing or managing a computer system that is governed by FDA regulations. A full understanding of how to assess the vendor’s practices is essential to ensuring compliance and is a first step in the validation of a computer system regulated by the FDA.
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.