Category: Validation

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Transforming Software Validation with Agile CSA

Presented by:Khaled MoussallyExecutive Vice President, Corporate Development & OperationsCompliance GroupSaradha RamamoorthyHead, Strategic Consulting – IndiaCompliance Group Inc.David .P.DelucaDirector, Strategic ConsultingCompliance Group Inc.Ken ShitamotoMS, Sr. Director ITGilead SciencesSenthil GurumoorthiPrincipal, Global Lead-Healthcare & Life Sciences, Security & ComplianceAmazon Web ServicesUnderstand Agile vs. Waterfall Methodologies: Explore the key differences between Agile and Waterfall approaches, and learn how each impacts […]

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Driving Organization Change in the Era of AI

Presented by: Diego Amesquita, Director, Business Transformation, Main & MissionThe 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 webinar, Driving […]

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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 SolutionsDiscussion 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 validation […]

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