Tag: Validation University Europe

Presented by: Connie Hetzler, Global Head – Validation, Alcon LaboratoriesTakeaways:• Regulatory guidance evolution• Global harmonization of regulations• Knowledge management – As a system that supports content• Organizational management for a systematic approach• Key challenges – Trends and looking forward To access this post, you must purchase MEMBER PLUS + or MEMBER PLUS 6M FREE.

Presented by: David W. Vincent, MPH, Ph.D. , Chief Scientific Officer, VTITakeaways:• The main aspects of a robust cleanroom management program• Challenges with cleanroom design and cleanroom materials of construction• Common deviation root causes for environmental monitoring failures• Cleanroom cleaning causing rouge, rust, and yellowing of surfaces• CAPA to improve cleanroom performance Takeaway Tools• Cleanroom […]

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Presented by: Donncadh Nagle, CQV Lead & Lecturer, Jacobs Engineering & TU DublinThis session features an article on a similar theme which I published this summer which highlights how emerging technology is empowering validation engineers to capture, share and transfer tacit knowledge.• Learn where Knowledge Management (KM) fits within the pharmaceutical and life science landscape […]

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