Tag: Cleaning

Cleaning Validation Demystified: A Comprehensive Guide and Case Studies

Presented by: John Wrenn, Country Manager, Australia & New Zealand , CAICleaning validation can be a confusing topic for many people as there can seem to be conflicting information and guidance. This webinar will give you a broad overview of cleaning validation and describe the history and fundamentals of cleaning validation and how we arrived […]

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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 holdup […]

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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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