Scrum Execution in Life Sciences & Pharma

You've been told to go Agile. But nobody told you how to run a sprint when every change needs a deviation report. Or how to write a Definition of Done when IQ/OQ/PQ validation is required. Or what a sprint review artifact looks like when it has to hold up in an FDA audit.

Standard Scrum training was not built for your environment. And most Agile coaches have never set foot inside a GxP facility. That's the gap this session is built for.

I've led Agile programs inside FDA 21 CFR Part 11-regulated environments — including a five-program portfolio at a medical device company spanning Siemens Opcenter MES, QAD ERP, Salesforce Health Cloud, and GitHub DevSecOps, all under GxP and CSV requirements. I've adapted sprint cadences to change control workflows, written user stories that satisfy validation protocols, and run ceremonies that produce audit-ready artifacts. Not in theory. In production.

This session is for Scrum Masters, PMs, QA leads, validation engineers, and IT managers in pharma, biotech, MedTech, or any regulated industry who are navigating the collision between Agile ways of working and compliance requirements.

We'll work through your specific situation — whether that's:

1. Adapting Scrum ceremonies to fit your validation and change control process
2. Structuring sprint artifacts for audit readiness
3. Handling CAB and CAPA workflows within an Agile cadence
4. Building a Definition of Done that works in a regulated environment
5. Coaching your team through the "but what about compliance?" objection

You'll leave with: Practical adaptations specific to your environment, clear answers to your hardest compliance-vs-Agile questions, and a concrete approach you can bring back to your team the next day.

Pre-call: Please share your current environment — industry, regulatory framework, tools, team setup, and the specific challenge you're navigating — at least 24 hours before the session. This is a working session, not a general overview, and the more context I have, the more useful it will be.