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 […]
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 […]
Presented by: John O’Neill, Stability Information Specialist, StabilityHubThe 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 in:• […]
Presented by: Emily Purchase, Project Manager, Quality, Compliance & Regulatory, CAIHaving 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 stability profile• […]
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