Created by: Ronald D. Snee, PhD, Snee Associates, LLC Snee-QbDTestMethodDevelopment-Pharm-ProcessingFeb2014Download
Created by: Chris Latoz & Kim Huynh-ba Combination products are therapeutic and diagnostic products that include two or more of the following: drug, biologic, and device. These products are needed for enhanced clinical outcomes and have more than one Mode of Action (MOA). Therefore, they require a more complex regulatory pathway and compliance with a […]
Presented by: Cody Beaumont, Associate Director, Quality Compliance and Regulatory, CAI Annex 1 and a Contamination Control Strategy are critical aspects of pharmaceutical manufacturing, focusing on maintaining quality, safety, and compliance as is expected in a regulatory setting. Annex 1 of the European Union’s Good Manufacturing Practice (GMP) serves as a guideline and cornerstone for […]
Presented by: Saurabh Joshi Shripad, Director for Solutions Engineering, ValGenesis, Inc. Ensuring the validated state of a cleaning process in an operational facility is complex, requiring a delicate balance of efficiency, compliance, and constant readiness. In this webinar, we’ll talk about how we can not only get this balance right but also make it even […]
Presented by: Jeff Ramos, Solutions Engineer, ValGenesis Change is the only permanent thing in this world. However, in Life Sciences, adapting to new norms may be slow and can lead to apprehension. Join us in this webinar to learn how you can mitigate those fears and take a path forward to adapt CSA in your […]
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