Welcome to the Automating Quality show sponsored by SOLABS, with your host Mandy Gervasio, Technology and Life Sciences industry veteran. The Automating Quality podcast is designed to provide professionals in the regulated Life Sciences industry with best practice perspectives as well as employable strategies and tools relevant to current industry trends. Listeners will come to understand pressing issues in the space and hear best in class thought leadership on various topics such as Quality, Training and Regulatory Compliance driven from an automation lens.
Automating Quality
Claim This Podcastby SOLABS, Mandy Gervasio, Philippe Gaudreau, and Guests
5.0(4 reviews)
66 episodes
Updated Weekly
Accepts GuestsHas SponsorsLocation 🇨🇦
27
Podcast Authority
BetaPoorBased on show quality, social media presence, reviews, charts, and more
Quality41
Social0
YouTube0
Engagement32
Podcast Overview
Welcome to the Automating Quality show sponsored by SOLABS, with your host Mandy Gervasio, Technology and Life Sciences industry veteran. The Automating Quality podcast is designed to provide professionals in the regulated Life Sciences industry with best practice perspectives as well as employable strategies and tools relevant to current industry trends. Listeners will come to understand pressing issues in the space and hear best in class thought leadership on various topics such as Quality, Training and Regulatory Compliance driven from an automation lens.
Language
🇺🇲
Publishing Since
6/25/2018
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27
Podcast Authority
BetaPoorBased on show quality, social media presence, reviews, charts, and more
Quality41
Social0
YouTube0
Engagement32
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Recent Episodes
April 23, 2026
Episode 66 - From Framework to Practice: Governing AI in GxP Environments with Niyati Patel
Mandy Gervasio and Philippe Gaudreau interview Niyati Patel, Strategic Quality and Compliance Advisor, on operationalizing AI governance in GxP environments, focusing on practical execution and human oversight.
April 7, 2026
Episode 65 - From CSV to CSA: Rethinking Validation in the Age of AI with Niyati Patel
<p data-start="24" data-end="178">Welcome to Automating Quality, the life sciences–focused show exploring how quality, risk, and technology intersect to modernize regulated environments.</p> <p data-start="180" data-end="576">In this episode, Mandy and Philippe are joined by Niyati Patel, Strategic Quality and Compliance Advisor with 20+ years of experience across pharma, biotech, medtech, and regulated digital implementations. Niyati specializes in the intersection of quality, validation, and digital transformation.</p> <p data-start="578" data-end="941">Together, they unpack how validation is evolving in the transition from Computer System Validation (CSV) to Computer Software Assurance (CSA). The discussion challenges common misconceptions, emphasizing that the real shift is toward risk-based thinking, lifecycle control, and deeper system understanding rather than documentation-heavy compliance.</p> <p data-start="943" data-end="1223">The conversation then moves into AI. Niyati outlines how organizations should rethink validation frameworks to focus on boundaries, governance, and human oversight, positioning AI as decision support rather than decision-making.</p> <p data-start="1225" data-end="1423">Through practical examples and real-world use cases, this episode sets the foundation for understanding how quality leaders can responsibly adopt AI while maintaining compliance, control, and trust.</p> <p> </p> <p>Key Takeaways</p> <ul data-start="1698" data-end="1808"> <li data-section-id="1p3oc60" data-start="1698" data-end="1808"> 01:09: Introducing today's topic</li> <li data-section-id="1ot4acl" data-start="1810" data-end="2022"> 03:24: Niyati's background</li> <li data-section-id="7ur6uo" data-start="2024" data-end="2251"> 05:43: What is CSV (and its limitations)</li> <li data-section-id="ix9r8a" data-start="2253" data-end="2505"> 09:06: What CSA actually changes</li> <li data-section-id="zdkn3l" data-start="2507" data-end="2739"> 10:41: Validation rigor is NOT reduced</li> <li data-section-id="khyxtp" data-start="2967" data-end="3212"> 14:00 Why AI breaks traditional validation</li> <li data-section-id="3hkj99" data-start="3214" data-end="3389"> 16:23: Why AI must be used for decision support, not autonomous decision making</li> <li data-section-id="1p0cy9h" data-start="3601" data-end="3857"> 19:13: Example of AI validation framework</li> <li data-section-id="1v3p45t" data-start="4304" data-end="4475"> 23:40: What validation now proves</li> </ul> <p>Please contact us at <a href= "mailto:solabs-podcast@solabs.com">solabs-podcast@solabs.com</a> if you have questions or comments.<br /> <a href= "https://www.linkedin.com/in/mandy-gervasio-lifesciencesleader/">Mandy Gervasio</a><br /> <a href="https://www.linkedin.com/in/niyatipatel/">Niyati Patel</a><br /> <a href="https://www.linkedin.com/in/pgaudreau/">Philippe Gaudreau</a></p>
February 16, 2026
Episode 64: Compliance in the Biotech Industry with Paul Michel
<p data-start="0" data-end="125">Welcome to Automating Quality, the life sciences–focused show that bridges the gap between automation and quality management.</p> <p data-start="127" data-end="516">In this episode, our host Philippe welcomes Paul Michel, Senior Consultant at SkillPad, with over 27 years of experience in the pharmaceutical and biopharmaceutical industries, including more than two decades in manufacturing. Paul specializes in GMP training, compliance readiness, and supporting organizations through the complexities of product development and commercial manufacturing.</p> <p data-start="518" data-end="932" data-is-last-node="" data-is-only-node="">Together, they explore the realities of GxP compliance in biopharma manufacturing — from the scientific complexity of biologics and evolving regulatory expectations to the growing demand for specialized quality skills and the expanding role of CDMOs. The conversation highlights how automation, digital maturity, and strong quality foundations are becoming essential to sustain growth in this fast-evolving sector.</p> <p> </p> <p><strong>Key Takeaways</strong></p> <p data-start="20" data-end="116">02:11 Why biologics manufacturing is fundamentally more complex than small molecule production</p> <p data-start="118" data-end="204">04:10 How living cell systems introduce variability and demand tight process control</p> <p data-start="206" data-end="291">05:29 Why scale-up in biomanufacturing is scientifically challenging and risk-prone</p> <p data-start="293" data-end="380">10:00 The role of ICH Q5 guidelines and comparability studies in biologics compliance</p> <p data-start="382" data-end="474">13:06 The growing demand for advanced quality skills in biologics and digital environments</p> <p data-start="476" data-end="570">17:18 How modern CDMOs enable faster development from DNA to IND through platform approaches</p> <p data-start="572" data-end="657" data-is-last-node="" data-is-only-node="">20:47 Why automation and digitalization are critical to closing the CDMO capacity gap</p> <p data-start="572" data-end="657" data-is-last-node="" data-is-only-node=""> </p> <p data-start="572" data-end="657" data-is-last-node="" data-is-only-node="">Contact Paul Michel on LinkedIn here: <a href= "https://www.linkedin.com/in/s3pharmavalidationconsultant/">Paul Michel (He/Him) | LinkedIn</a></p> <p data-start="572" data-end="657" data-is-last-node="" data-is-only-node="">Contact us at <a href= "mailto:solabs-podcast@solabs.com">solabs-podcast@solabs.com</a> for questions or feedback!</p>
66 total episodes available with 3 transcripts
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- What is Automating Quality?
- How often does this podcast release new episodes?
This podcast updates weekly.
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This podcast is available on 9 platforms including Apple Podcasts, Spotify, and more. You can also use the RSS feed directly.
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No, this podcast does not typically feature guests.
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