Category: Conference Sessions

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Steps to a Successful Cleaning Cycle Development and Validation to Support Lifecycle Approach

Presented by: David Vincent, Ph.D, Chief Scientific Officer, VTI Life Sciences • Current regulatory expectations• Life cycle approach to cleaning validation (FDA 3 stage approach)• How to gain cleaning process understanding by utilizing risk based approach• CIP and automated systems design and qualification of equipmento equipment selection clean by designo sprayball coverage studieso washout curveo […]

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A Risk Based Approach to Developing and Maintaining an Environmental Monitoring Program

Presented by: Anthony Grilli, CEO and Owner, FOCUS Laboratories Sampling air and surfaces with agar plates for colony forming units in a manufacturing plant to assess effectiveness of contamination controls measures a blunt, labor intensive tool providing data a week or more after sampling. Shortages of media from suppliers due to Covid or natural disasters […]

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Going Paperless Case Study: Understand the Value and ROI of Digitization Platforms

Presented By: Geetanjali Abbi, Director, Digital Quality Assurance, Alkermes This case study is intended to walk the audience through the transformative journey that Alkermes has been through since our initial transition to ValGenesis 7+ years ago. This will include a discussion on how ValGenesis helped us sustain the workload during the pandemic, lessons learned (both […]

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Superintelligence Governance: Advancements vs. Ethics – How to Safely Use Advanced Technologies and Avoid a Catastrophe

Presented By: Steve Thompson, Senior Director Product Marketing, ValGenesis • Recent technology advancements that are promising and problematic? • Learning from our past mistakes – How catastrophes became the catalyst for regulatory action • Assessing our current risk management process(es) • Establishing governance for advanced technologies • Knowing who’s ultimately responsible, and how to protect […]

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