Category: Article

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Cleaning Validation Equipment Grouping

Grouping equipment for cleaning validation is a common practice for reducing execution, resources, and production downtime.  Though regulatory [1] [2] and industry guidelines [3] support the practice and provide guidance, there is a clear requirement for scientific justification. Common industry practice is to either avoid grouping because of perceived risk or base the grouping only […]

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Role-based Talent Planning for Operational Readiness

This paper intends to provide guidance on talent planning, with specific emphasis on role clarity. Given the flurry of activity being conducted during capital projects and transitions to operations, developing a talent plan may appear to be somewhat administrative or insufficiently urgent. This often leads site leaders to forego a focused and thoughtful talent planning […]

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High Stakes Change Management: Remediation Post FDA Warning Letter

Your company has received an FDA warning letter, now what? As an organization finds itself in uncharted waters due to inspection results, the leader’s job is to chart a course and speed to re-inspection success without everyone jumping ship. Leaders must remember historical averages for change success hovers between 30-50% (Adam & Danaparamita, 2016; Beer […]

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Emerging Technologies in the Pharma and Life Sciences Industry — Mixed Reality

Emerging technologies are quickly playing a greater role in how the Pharmaceutical and Life Sciences Industry collects, stores and interprets its data. Mixed Reality platforms are becoming more widespread in the application of displaying andinterrogating this data. This paper summarises the trials of an initiative supported by KENX USA, TU Dublin and BioPharmaChem Ireland (BPCI). […]

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How to Benefit from the Computer Software Assurance Guidance

The Food and Drug Administration (FDA) has recently proposed dramatic changes to the current Computerized System Validation (CSV) approach that is being used by most companies in the Life Science Industry. Although not yet released, the proposed Computer Software Assurance for Manufacturing, Operations, and Quality System (CSA) guidance will assist manufacturers overcome several barriers to […]

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