Conference Sessions Archives - Page 5 of 8 - Kenx Members

Category: Conference Sessions

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Overcome Top Challenges in Cleanroom Management, Environmental Monitoring and Environmental Cleaning – Insight from the Front Line

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 […]

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“Process Validation, What’s missing? – The Role of Knowledge in Talent Development Through the Use of Emerging Technologies and Digitalization

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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Stability Chambers Selection, Validation, and Calibration

Presented by: John O’Neill, Stability Information Specialist, StabilityHub The right chamber for the right application takes your organization from samples to registration and beyond. Whether operating your own or using that of a contractor you’ll want to make sure the chambers you use won’t let you down. This session takes a User’s point of view […]

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Understanding FDA’s Revised OOS Investigation Guidance

Presented by: Emily Purchase, Project Manager, Quality, Compliance & Regulatory, CAI Having a diverse group of suppliers can provide the expertise and innovation needed to outperform the • Establish stability protocols to deliver the right analytical informations• Establish key information to manage changes to the stability programs• Identify and investigate stability deviations to support product […]

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Sustainability Case Study: Differentiate To Innovate! Innovation Through Supplier Diversity

Presented by: Luiz Barberini, Operations Manager, External Manufacturing, Bayer Having a diverse group of suppliers can provide the expertise and innovation needed to outperform the competition. An effective supplier diversity process can have a powerful and positive effect on the strength and loyalty of any organization’s consumer base – but to implement a strong supplier […]

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