Webinar Archives - Page 3 of 7 - Kenx Members

Category: Webinar

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

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 competitive advantage? […]

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Cleaning Contamination Control Program

Presented by: David W. Vincent, MPH, Ph.D., CEO and Chief Scientific Officer, VTI Life Sciences This Webinar recording will cover the following: Regulatory Requirements: Contamination Control Strategy & Cross Contamination• The view of EU GMP Annex 1• The view of US-FDA: Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice• ASTM – […]

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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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Selection of Analytical and Sampling Methods for Cleaning Validation Based on Analyte Characteristics

Presented by: Michael Lund, Program Manager, Hyde Analytical Laboratories Analytical testing, coupled with a robust sampling method with high recovery, is essential to confirm equipment surfaces have been properly cleaned during cleaning validation or verification. The selection of an appropriate cleaning analytical method is integral to the accuracy of test results generated during cleaning validation […]

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Fundamentals of Temperature Mapping for Controlled Environments

Presented by: Hector Felix, Senior Validation Engineer at VTI Life Sciences This webinar will cover the best practices you must implement whether you ship or store temperature-sensitive products. Participants will learn about the regulator context, what has to be done, and how with real concrete examples and case studies. The course details will include: DefinitionTemperature […]

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