Leucine Podcasts
Conversations with quality leaders, manufacturing heads, and the Leucine team on AI agents, regulatory compliance, and digital transformation across pharmaceutical operations.
All Episodes
Role of AI in Pharma Manufacturing: Early Warning Systems, Incremental Automation, and the Path from Paper to Digital
A 30-year pharma veteran discusses why FDA observations keep repeating, why APRs are a ritual rather than an improvement tool, and how companies should actually approach the transition to AI.
Digital Transformation at Dr. Reddy's: MES, Leadership Buy-In, and AI as a Copilot for Root Cause Investigations
Dr. Reddy's Head of Digitization on the 15-year digital journey starting with MES, why leadership vision is the prerequisite for transformation, and how AI will act as an expert copilot for pharmaceutical investigations.
Risk Mitigation and Anomaly Detection: Managing Quality at Scale and Why AI Adoption Must Go Slow
Centaur Pharmaceuticals' VP Quality on the unique complexity of billion-tablet-scale pharma manufacturing, how AI can drive risk mitigation and anomaly detection, and why adoption must be incremental.
Cleaning Validation: HBEL Limit Setting, Visual Inspection, and the Shift to Ongoing Process Verification
Ecolab's global cleaning validation expert on why incorrect limit setting is the industry's top mistake, how health-based exposure limits replace outdated 10PPM criteria, and why ongoing process verification is the next major trend.
FDA Inspections: All-Time Audit Readiness, Data Integrity Culture, and Why You Cannot Prepare for an Inspection
Dr. Abhay Gaitonde — a senior pharma quality leader — on why inspection preparation is the wrong framing, why data integrity is a cultural problem, and the unresolved challenge of validating self-learning AI.
Root Cause Analysis: Multivariate Failures, HPLC Productivity, and Why the First Root Cause Is Almost Never Right
A Six Sigma expert on why batch failures are multivariate like car accidents, how AI found humidity as a root cause humans missed, and how RPA cut the reviewer-to-analyst ratio from 1:5 to 1:10.
Electronic Batch Records: From 4-Page Documents to 150 Pages, and What Comes After Digitisation
Pharmaceutical manufacturing veteran Shirish G Belapure on the four-decade evolution of batch records, why tablet-making technology is unchanged while documentation has exploded, and where the industry sits on the path to lights-out manufacturing.
Quality Culture and AI in QMS: Asking the Right Questions, Knowledge Management, and the Body Language of Your Organisation
Qualtivate CEO Harsh Thakkar on why quality culture is the body language of an organisation, how AI unlocks QMS knowledge management, and why asking the right question matters more than having the best AI tool.
Operational Excellence in Pharma: OEE, Cost of Poor Quality, and Why QMS Investments Underdeliver
Syngene's operational excellence leader on why pharma's QMS and MES investments haven't reduced deviations or improved efficiency — and what the missing intelligence layer looks like.
MES Implementation in Indian Pharma: Pioneering Digital Manufacturing, Overcoming Cost Barriers, and Reducing Process Variability
The pioneer of MES implementation in Indian pharma on why mid-sized companies face cost and product-fit barriers, how to distinguish GMP limits from control limits, and why LIMS, QMS, and MES together cover 90% of compliance needs.
See how Leucine's AI-native platform is transforming pharmaceutical quality and manufacturing operations.
