Q. Please tell us about yourself. What brought you to your current position?
I am Naresh Desai, the founder of ValSupport, Inc., a value staffing and consulting support company. I started my career working at companies like Abbott, Amgen, BioGen, Cordis, Gilead, MedImmune, and a few other smaller organizations. Throughout this journey of over two decades, I have been in the quality and compliance field.
During this time, we encountered challenges in understanding our hiring requirements for permanent and temporary positions. It was difficult to find a company that charges reasonably and provides high-quality resources. This led us to the idea of starting a company that takes away the hiring manager’s burden of reference checks, background compatibility assessments, and technical and cultural fit evaluations. Above everything, there is only a minimum to no placement charge for our clients—we’re proud and honored to support them.
Q. What is your favorite part of the work you’ve done in this field?
It’s always been a challenge to incorporate compliance advances in the fast and technologically evolving biopharma industry. I have been involved with 21 CFR Part 11 and the European Commission’s Annex 11 implementation for a long time, however, the MHRA GxP Data Integrity Guidance and Definitions launch in 2018 made huge movements—especially in the lab automation/semi-automated laboratory systems space. We have implemented multiple data integrity programs since then to help clients meet the current compliance standard.
Q. What is your talk about?
My talk is on implementing ALCOA++ principles in laboratory automated systems. We will discuss the most important elements of data integrity to consider and corresponding best practices. We will go over a few examples during the talk and explore the ALCOA++ principles in depth.
Q. Why do you think it’s important to discuss this topic with our audience?
In today’s world, we use the latest technology to bring convenience to our lab operations. This convenience comes with automated processes or robotics. These systems cannot be fully automated, and therefore, come with chances to manipulate and modify. Understanding data integrity is critical and allows for controlled edits, and I hope this talk helps clarify that.
Naresh Desai is the founder of ValSupport, Inc., a staffing and FDA compliance consulting company. As a leader in FDA compliance and quality, he brings over 20 years of experience from leading organizations in the pharmaceutical, biotech, and medical device industries. Throughout his career, Naresh has held pivotal roles at renowned companies, such as Gilead Sciences, Abbott Vascular, Amgen Inc., MedImmune (AstraZeneca), Biogen Idec, and Cordis (a Johnson & Johnson company). Naresh has been instrumental in transitioning organizations to modern validation methodologies, including CSA and GAMP 5 risk-based approaches. With expertise spanning validation, compliance, and quality systems, he has represented organizations during FDA audits, resolved data integrity challenges, and developed strategies for De Novo Class II submissions. Naresh holds a master’s degree in chemical engineering and certifications in the Medical Device Single Audit Program (MDSAP) and Clinical Trial Program Management.
Register today for free to attend Naresh’s and other insightful webinars at the 2025 Laboratory Quality and Compliance Week!
