Category: Webinar

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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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Annex 1 & Contamination Control Strategy

Presented by: Cody Beaumont, Associate Director, Quality Compliance and Regulatory, CAIAnnex 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 sterile […]

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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 better […]

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