Risk, Quality, and Inspection Readiness

Gautam Pangu, Associate Director of Biologics CMC Project Management at Incyte, leads a breakout session on managing risk and quality in regulated program delivery. Pharma and biotech programs operate under intense regulatory scrutiny, and the ability to proactively identify, assess, and mitigate risks while maintaining quality standards is a core competency for successful program managers.

Gautam will present a practical risk management framework tailored to the unique requirements of regulated environments, including how to integrate risk management with quality systems, prepare for regulatory inspections, and build a quality-first culture within project teams. The session will include real-world examples from biologics development programs.

Attendees will leave with actionable techniques for strengthening risk and quality management in their own programs, along with templates and tools they can adapt to their organizational context.