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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