Presented by: Donncadh Nagle, CQV Lead & Lecturer, Jacobs Engineering & TU DublinThis session features an article on a similar theme which I published this summer which highlights how emerging technology is empowering validation engineers to capture, share and transfer tacit knowledge.• Learn where Knowledge Management (KM) fits within the pharmaceutical and life science landscape […]
Created by: John O’Neill, Editor, StabilityHub.comStability excursions are unintended lapses in the control parameters (such as temperature, relative humidity, and light) which are designed to preserve a product at experimental, manufacturing, shipping, and patient environment conditions. Significant excursions bring into doubt the validity of data generated in stability studies and the integrity of product during […]
Created by: Matthew Jackson, Validation Manager, Torbay PharmaceuticalsThis article was based on my session, Cleaning Validation Program Design: Risk-based Lifecycle Approach, delivered at the KENX’s Cleanroom Validation, Disinfection & Environmental Monitoring Conference April 27-29, 2022 Virtually and in person in Philadelphia, PA.KENX’s hybrid conferences highlight those paving the way in best practices in cleanroom qualification, […]
Created by: Fred Ohsiek, Senior Global Technical Manager, Life Science (Cleaning Validation) for Ecolab in North AmericaDeveloping an automated clean-in-place (CIP) recipe is a challenging activity for project such as a new facility, equipment or wing addition to an existing facility, a new product, or optimizing a legacy cleaning process. This article will focus on […]
Presented by: Ken Shitamoto, Executive Director, Gilead Sciences• Define a validation program and GAMP5 V model• Define training scope for validation program and processes• Designing training curricula for validation team• Test/protocol execution training: Testing process and acceptance criteria review• Pre and post execution – Must dos and don’ts awareness• Data Integrity training in validation programTakeaway […]
