Category: Conference Sessions

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

Presented by: Anthony Grilli, CEO and Owner, FOCUS LaboratoriesSampling 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 exacerbate […]

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

Presented By: Geetanjali Abbi, Director, Digital Quality Assurance, AlkermesThis 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 positive […]

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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 yourself and your companyTakeaway […]

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Establishing CAPA to Support Your Investigation And Promote Continuous Improvement

Presented By: LeAnna Pearson, Associate Director Quality Compliance & Regulatory, CAIPart 1 – CAPA 101 back to basics• Understand the purpose and history behind the CAPA• Understand what the FDA is expecting from your CAPA• Understand when to use a CAPA• Review the typical CAPA processPart 2 – Building blocks of an effective CAPA Strategy• […]

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