Stability considerations for drug-device combination products-21 CFR part 4 update

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 […]

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Annex 1 & Contamination Control Strategy

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 […]

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Managing Cleaning Validation at an Operational Facility

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 […]

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What’s Stopping You? Overcoming CSA Adoption Concerns

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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The Impact of AI on the GxP Landscape

Presented by: Rosalind Beasley, CEO and Co-founder, Main and Mission, Inc.Tim Kirkelie, Med Tech Executive / consultant, Main and Mission, Inc. Discover how AI technologies are reshaping the future of compliance, quality control, and data management processes.  Gain valuable insights from industry experts and learn how to leverage AI to navigate challenges and drive innovation […]

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