Why does tech transfer remain so hard in pharma , even when every document is neatly in order? Paige Kane, PhD, CPIP, Associate Vice President of Technical Excellence & Transformation at CAI, has spent about 25 years on technology transfers for clinical and commercial supply, and earned a PhD studying exactly that question.
She joins Nick Capman to talk about moving the knowledge a receiving site needs, not just the documents and processes.
They discuss:
Why tech transfer could happen by FedEx if documents held everything
The difference between know-what and know-why
Treating risk assessments as knowledge capture documents
Using a structured pre-job brief to surface what teams need to know
How a facility ran 47 batches right first time
Why QC and QA are so often left until the end
The case for plant-floor video as a knowledge transfer tool
Making lessons learned travel with the product
About Paige Kane, PhD, CPIP
Paige Kane is Associate Vice President of Technical Excellence & Transformation at CAI, with more than 30 years in biotech and pharma. She previously led Merck’s Knowledge Management Center of Excellence, is a regulatory science researcher at Technological University Dublin, where she earned her PhD, and has authored and contributed to numerous ISPE guidance documents, including GAMP 5 and the ISPE Knowledge Management Good Practice Guide.
About The FDA Group
The FDA Group helps life science organizations rapidly access the industry’s best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more: https://www.thefdagroup.com/
