Category: Webinar

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Driving Organization Change in the Era of AI

Presented by: Diego Amesquita, Director, Business Transformation, Main & Mission The rapid adoption of Artificial Intelligence (AI) in the Life Sciences industry is transforming how organizations operate, think, and govern. As AI reshapes the landscape, it is imperative to implement robust Organizational Change Management (OCM) strategies to ensure a smooth and successful transition. In this […]

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How to Enable Validation/Pharma 4.0 Through Digital Validation and Emerging Technologies

Presented by: Philip Jarvis, Director Integrated C&Q and Paperless Strategy, Veqtor Solutions Discussion on how emerging technology such as AI/and machine learning has the potential to change the world of validation , and help achieve validation 4.0 principles . How do we create a digital validation ecosystem ,create data integrity by design, and harness digital […]

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Regulatory Requirements and Standards for Medical Device Validation & Verification

Presented by: Ritam Priya, Consultant, MDRQ Consulting Manufacturers (including software developers) need to gather objective evidence of performance, safety and efficacy to support both their premarket authorization/registration in different markets and postmarket changes. Regulatory requirements are defined by different regulators for product compliance and different committees like ISO, AAMI and IEC that develop standards to […]

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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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  • Phone: 858 649 3251
  • Email: info@kenx.org
  • Phone: 858 649 3251
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