Category: GMP

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Shared Responsibility Model and Use Cases for Decentralized Technology in Life Sciences

Presented By: Dori Gonzalez-Acevedo, Co-Founder and CEO, ProcellaRX & Tanya Sharma, Co-Founder, Assurea Forward-thinking organizations are finding new and innovative ways to utilize blockchain and decentralized ledgers in their business processes, but for many this is still uncharted territory and brings with it many uncertainties. This is certainly true in the life sciences industries where […]

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Best Practice Approach to Operational Readiness – Creating a Competitive Advantage through your Workforce

Presented by: Presented by: Harry Benson, Global Director, Human Performance Have your ever considered whether your company or site workforce is any different from any other site or company? If so, what makes it so? If not, what’s missing?How can we turn our most costly and variable asset – the organization’s people – into a […]

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Data-driven Risk Management: How to Minimize Subjectivity

Presented by: Pedro Ferreira, Head of Validation and Quality and Risk Management Services, ValGenesis® ICH Q9(R1) introduced the need to manage and minimize subjectivity in risk management in order to enhance scientific sound risk based decision making. In this presentation, a practical approach to respond to this need is outlined in the context of a […]

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Conduct a Change Control Impact Assessment

Presented by: Joscelyn Bowersock, Customer Success Manager, L7 Informatics Part 1 – The Change Control System• Why is a change control system needed?• When does the change control system need to be implemented?• Project change control versus quality change control• Review an example of generic change control process flow• Paper versus electronic change control systems […]

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