Welcome to the first episode of the Navigating the Combination podcast!
When Jeff Gensler walked into Pfizer Meridian on day one, FDA had left the building just a week earlier. What followed — a warning letter response, 15 FDA meetings in four months, a CDRH site audit, and an agency directive to redesign the entire product — was a challenge, but also an opportunity for in-depth examination of the company’s quality systems. In this episode, Jeff joins Parth and Jonathan to unpack those early days, the gaps he found between pharma and device quality thinking, and how that experience shaped his entire approach to process capability, CAPA, and compliance.
Jeff breaks down why the transition from attribute to variable data is so much more than a methodology switch — and shares a real example of how catching a single worn mould cavity early saved millions of dollars in scrapped components. He also makes the case for why quality professionals need to stop speaking compliance-only and start building business cases that leadership can actually act on. Now Chief Quality Officer at Exela Pharma Sciences, Jeff reflects on what the shift to the CDMO space looks like, where the industry is heading, and why he believes quality is becoming a competitive advantage rather than a cost center.
Key takeaways:
Pharma and device quality systems differ fundamentally in CAPA philosophy - pharma treats CAPA as actions from investigations, while device uses it systemically for trend violations and major issues
Switching from attribute to variable data requires process improvement work first — you'll surface capability gaps that were invisible before
Variable data allows earlier detection of process drift, as demonstrated by catching a degraded mould cavity before a single out-of-spec part was produced
Quality improvements need a business case, not just a compliance argument — linking changes to cost savings significantly increases the chance of leadership buy-in
Process validation should go deeper than IQ/OQ/PQ checkboxes — centring processes within OQ limits prevents failures down the line
Continuous process monitoring catches variation sources that a three-lot PQ simply cannot represent CDMOs are often out of sight with FDA — building a proactive quality culture internally is both a compliance strategy and a market differentiator
Run towards the fires — warning letters, drug shortages, and enforcement actions are where quality professionals learn the most, fastest
Connect with Jeff Gensler on LinkedIn: https://www.linkedin.com/in/jeff-gensler-67a54a1a/.
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– Parth & Jonathan and the Navigating the Combination podcast team
Connect with Parth Kothari on LinkedIn: https://www.linkedin.com/in/parthjkothari/ Connect with Jonathan Amaya-Hodges on LinkedIn: https://www.linkedin.com/in/jonathanwhodges/ Visit the Suttons Creek website here: https://suttonscreek.com
Listen to Navigating the Combination on these podcast platforms:
Spotify: https://open.spotify.com/show/033HRTwEj7aFLx9K8ZEsVG
Apple Podcasts: https://podcasts.apple.com/us/podcast/navigating-the-combination/id6786238670
Amazon Podcasts: https://music.amazon.com/podcasts/12169e2d-2323-41db-bdb4-8a8e7841c799
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Navigating the Combination is the podcast for pharmaceutical and biotech professionals tackling one of the industry's most complex challenges: bringing drug-device combination products to market. Hosted by Parth Kothari and Jonathan Amaya-Hodges of Suttons Creek - the device team for pharma - each episode draws on 650+ combined years of experience and 120+ successful launches to cut through the complexity of combination product development, from device selection and regulatory strategy to OEM alignment, quality systems, and FDA submissions.
Whether you're a VP of Regulatory Affairs weighing your submission strategy, a program director managing a complex OEM relationship, or an executive trying to protect a multi-million-dollar drug investment, this podcast gives you the insight, clarity, and confidence to make the right calls - right the first time.
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