Professional Activity

How to build a CCIT program that holds up in an inspection: deterministic versus probabilistic methods, matching the method to vials, prefilled syringes, and cryobags, validating the method itself, and testing at the right points across the lifecycle.

How to run deviations, root cause investigations, CAPA effectiveness verification, and change control across a network of contract manufacturers, from what the quality agreement actually buys you to the metrics that reveal a partner's quality system drifting.

How to run the technical assessment, capability, capacity, culture, equipment fit, analytical readiness, and data systems, that turns CDMO selection into a defensible technical agreement instead of a leap of faith.

What INDs, NDAs, and BLAs actually require for process validation content, how to write S.2.5 and P.3.5 sections and PPQ summaries a reviewer can follow, and how to handle review-cycle questions and pre-approval inspection readiness.

How to build a Stage 3 CPV program that catches process drift before it becomes an OOS, covering parameter selection, control charts versus capability indices, escalation rules, and right-sizing for batch volume.

How to qualify the cold chain for cell and gene therapies: shipper types, shipping study design, real-time monitoring and alert escalation, reverse logistics, customs and import contingency planning, and how a temperature excursion actually gets investigated.

How to build a sterilizing-grade filter validation package: bacterial retention studies with the manufacturer, product-specific versus matrix bracketing, the extractables handoff, routine integrity testing, and the traps that catch low-volume programs.

How formulation logic shifts from proteins to oligonucleotides to cells to AAV vectors: stability drivers, excipient choices, custom cryoformulation development, mixing equipment selection, lyophilization cycle basics, and what changes at high concentration heading toward a prefilled syringe.

What carries and what breaks when the same validation instinct moves from small molecule tablets through medical devices, RNAi-LNPs, oligonucleotides, autologous cell therapy, gene therapy, and now RNA editing.

Person-in-plant oversight at a CDMO: what to watch on the floor, virtual versus on-site models, and how to drive CAPA to closure without becoming the contractor's second QA unit.

What Process Performance Qualification readiness actually requires: the process, analytical, documentation, and CDMO prerequisites that decide whether a PPQ campaign succeeds, checked before batch one starts.

How to run a technology transfer for cell, gene, and RNA therapeutics: the document spine, phase-appropriate rigor, engineering runs, and the handoff criteria that make a transfer actually done.

What a Validation Master Plan is for, how to scope it by risk instead of habit, and how to keep it a living document an inspector can actually follow.