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The FDA Group’s Nick Capman recently sat down with Jeff Brenneman, Vice President of Global Operations Quality at Alora Pharmaceuticals. With over 25 years of experience in pharmaceutical manufacturing, spanning branded, generic, and OTC products, Jeff brings a deep perspective on sustaining inspection readiness across multiple sites while leading global quality teams.
Jeff shares why, despite the news of the FDA implementing better site targeting and prioritization tools, inspections feel less predictable today—with more variability in inspector experience and a higher likelihood that minor issues will become formal observations—and how leaders can respond without overreacting.
He explains how to prepare documentation so that it’s understandable to any inspector, what makes a quality system truly “robust” in practice, and why culture, accountability, and simplicity matter as much as compliance.
Nick and Jeff also explore practical steps for keeping data integrity controls sharp, building efficient systems that don’t overburden teams, and fostering engagement so quality is seen as a partner, not just a policing function.
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Jeff’s key takeaways and recommendations
If you’re short on time, here are standout insights from this episode.
Expect inspection variability—and prepare accordingly. With staffing changes at the FDA, you may see more junior inspectors and less discretion on what becomes an observation. Be ready for a higher volume of 483 items and respond proportionately without overreacting.
Write for an outsider. Investigations, risk assessments, and procedures should read in plain language so an inspector unfamiliar with your product or acronyms can follow the logic from problem → context → facts → conclusion. It lowers flags and speeds reviews.
Define “robust” the right way. A modern quality system is simple, efficient, and compliant—with procedures that don’t contradict each other, crystal-clear roles, targeted training (only who needs it), and clean handoffs between processes. Your eQMS is a tool; procedures are the backbone.
Move beyond checklists. Translate compliance requirements (e.g., data integrity) into product and system quality, unifying where possible to avoid duplicate “check-the-box” work and maintain focus on patient safety and business impact.
Data integrity basics still win the day. Audit trails on and reviewed, correct access roles, tested backup/restore, and readiness to demonstrate controls live. Challenge systems routinely (quarterly/annually) so you’re never surprised during an audit.
Performance under constraints. Cost pressure and leaner teams require intentional simplicity, Lean/Process Excellence habits, and clarity to do more with less—without slipping on compliance.
Culture = engagement + accountability. Hold regular 1:1s to surface issues and give direct feedback; build cross-functional careers so quality stops being “the police” and becomes a true partner to operations, supply chain, and commercial.
One thing to bring back to your team
Rewrite one high-visibility procedure and its training plan for simplicity and clarity. Align roles, remove contradictions, trim “train everyone” habits, and make sure the investigation template leads with plain-English context before technical depth. Then dry-run it with a non-expert reader.
Jeff Brenneman is Vice President, Global Operations Quality at Alora Pharmaceuticals, providing quality oversight across Alora’s network (including sites in GA, FL, NJ, and TX) and leading initiatives such as corporate-wide policy harmonization, on-time release, and MasterControl QMS deployments—while supporting SAP implementation and Lean/5S improvements.
Previously, Jeff served as Director of Quality at Osmotica Pharmaceuticals (site leadership across manufacturing, packaging, labs, validation, and PD), where programs he led helped reduce deviations, maintain no FDA 483s since 2019, and avoid missed shipments and recalls. Earlier roles include Site Quality Director at Oxford Pharmaceuticals, QC leadership at Par/Qualitest, and QA supervision in solid oral dose operations.
Connect with him on LinkedIn here.
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