Presented by: Connie Hetzler, Global Head – Validation, Alcon Laboratories Takeaways: • 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
Presented by: David W. Vincent, MPH, Ph.D. , Chief Scientific Officer, VTI Takeaways:• 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 […]
Presented by: Donncadh Nagle, CQV Lead & Lecturer, Jacobs Engineering & TU Dublin This 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 […]
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