This episode has been published on May 21st, 2019
Welcome to the 21st episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends!
This week, Mandy is joined by her co-host, Philippe Gaudreau, the CEO of Solabs, as well as their guest, Michael de la Torre. Michael is Chief Executive Officer of Govzilla (now Redica Systems) — the leading platform for GxP inspection analytics. As a company, they are leveraging the power of Big Data and Machine Learning to make government data accessible, usable, and valuable to everyone who needs it.
As the life sciences industry continues to evolve, with regulatory compliance remaining a critical factor for success, inspection trends are a tool to help companies to develop and enhance their quality management systems. Additionally, being aware of these current trends is a key factor for developing a robust audit readiness program. If you or your industry colleagues are seeking a good tool to enhance your understanding of inspection trends, you do not want to miss this week’s episode!
[:29] About today’s episode.
[1:20] Michael introduces himself, his expertise background, and his company, Redica Systems.
[3:29] Michael speaks about the most important recent FDA inspection and enforcement trends.
[7:49] What are the top items cited by the FDA in human drugs? And have there been any changes in the last couple of years?
[12:22] Michael speaks about changes in the inspection scope since the issuance of the data integrity guidance in 2018.
[16:11] Michael’s take on Cloud-based solutions for the life sciences industry.
[18:15] What impact has the FDA had on the market with their efforts on being more open and transparent with their inspections and enforcement data?
[22:53] How Redica Systems could be incredibly useful for your organization!
[23:18] Mandy and Philippe thank Michael for joining them this episode.
[25:02] How to get in touch with Michael de la Torre and Mandy Gervasio.
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