In this episode, we’re joined by Paul Daniel, Senior GxP Regulatory Expert of Vaisala, who brings nearly 30 years of experience in pharmaceutical validation and temperature mapping. Paul shares the evolution of mapping from a technical task to a regulatory imperative, unpacking the misconceptions, equipment considerations and quality frameworks essential for accurate, compliant execution.



Key Takeaways:

(04:19) Modern data loggers reduce manual steps and lower mapping error rates.

(07:00) New mapping guidance added complexity and confusion to established practices.

(10:22) Mapping provides documented evidence your CTU operates in a controlled state.

(12:33) Misunderstanding mapping as simple logging indicates the lack of a validation framework.

(15:05) Superior equipment improves data quality and helps navigate inevitable deviations.

(23:26) If you don’t understand the tools, it’s time to outsource.

(26:28) Warehouse automation can streamline mapping with robotic logger placement.

(33:50) Deviations expose real-world system behavior and improve validation expertise.

Resources Mentioned:

Paul Daniel

https://www.linkedin.com/in/paul-daniel-37176518/

Vaisala | LinkedIn

https://www.linkedin.com/company/vaisala

Vaisala | Website

https://www.vaisala.com/en

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For more information, visit www.perfval.com. 

#cGMPCompliance #FDARegulations #QualityAssurance #CQV