Dr. Teri Stokes
Founder & Senior CSV Consultant at GXP International, USA
For the last 30+ years, Dr. Teri Stokes has been a global consultant, auditor, trainer, and practitioner in computerized system validation (CSV) practices. She has been an invited speaker at industry conferences in Europe, North America, and Asia. Her third and most recent book “Computer Validation: A Common Sense Guide” was published in 2011 It uses anonymized examples from real client projects to illustrate CSV concepts and documentation in a practical way.
From 2016 – 2018 Dr. Stokes served as QA Director for CSV at Cytel, Inc. In this role she introduced the corporate CSV policy and established CSV practices for Cytel across India, North America, and Europe. This included training and mentoring validation teams to perform Operational Qualification (OQ) for software development in Pune, Installation Qualification (IQ) for the corporate infrastructure based in the US, and end user Performance Qualification (PQ) for multiple clinical data systems used across India, North America, and Europe.
From 2015 – 2018 Dr. Stokes was contributing editor to “Good Clinical Practice: A Question & Answer Reference Guide” published by Barnett International. The topic for her section of this Reference Guide is “Computerized Systems, Electronic Records, and eData Integrity.”
Now Dr. Stokes has returned to her private CSV consulting business as Founder & Senior CSV Consultant at GXP International, 131 Sudbury Road, Concord, MA 01742 – USA.
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. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects.
During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation.
Carolyn has participated in industry conferences. She is currently active in the PMI, AITP, and RichTech, and volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.
CSV & FDA Expert
CEO of Infra Control Systems
Kalpesh Kumar Vaghela, is the CEO of Infra Control Systems. He has 30 years experience as Software Validation Specialist, Expert Trainer CSV, cGMP, Data Integrity, GAMP5, 21 CF Part 11 Compliance, ICH Q9, Risk Assessment. He has also worked in Elecronics and Instrumentation Engineering fields. Since last two decades Mr. Vaghela has been helping Indian and International Pharma Companies achieve Compliance by training and motivating professionals for Right First Time Approach. He has supported many USFDA, MHA, ANVISA, MCC, TGA Customer Audits, as a consultant.