Presented by: Rui Almedia, Director, Product Life Cycle Management Services, ValGenesis. Inc. Cleaning validation is a complex process. Over the years, the industry has moved on with a structured risk based lifecycle approach following FDA Process Validation Lifecycle principal guidance. Using old processes, it remains a challenge to eliminate human errors. This presentation shows how […]
Presented by: Philip Jarvis, Director, Integrated C&Q and Paperless Strategy, Veqtor & Mark Geldard, Director Sales EMEA, Kneat • Discuss how to develop ROI and momentum for a transition to paperless C&Q • How to influence key stakeholders, and build a culture of digital transformation • Key watch outs and learnings including: o Education on […]
Presented By: Tara Scherder, partner, Synolo Stats, LLC MOVING-TO-OBJECTIVE-DATA-DRIVEN-DECISIONS-THE-WHO-WHAT-WHEN-WHERE-WHY-AND-HOW-OF-STATISTICSDownload
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 […]
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