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Webinar

Modernizing CSV: How AI and CSA Are Changing the Game

Time

Webinar length

60 minutes

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Webinar details

Join PwC and Kneat for a practical look at how life sciences companies are rethinking validation. We’ll explore how AI tools and Computer Software Assurance (CSA) principles can simplify documentation, improve speed and accuracy, and reduce compliance risk — backed by real-world case studies and examples.

What You'll Learn

  • How AI is helping transform validation: Reduce manual scripting, streamline reviews, and increase process consistency using generative AI and automation.

  • Readiness and compliance: What’s required to validate AI-based systems— updated SOPs, new review criteria, and smarter team structures.

  • Success Story: QMS transformation: How a life sciences company implemented a cloud-first, AI-enabled QMS with PwC.

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Speakers

Senior Process Engineer, Kneat

Amy Wilhite

Amy is a highly experienced validation engineer with a demonstrated history of excellence in the biotechnology industry. She is an expert in laboratory operations, bioprocess manufacturing, and equipment/facility/utility CQV. 

Senior Manager, Digital Quality & Validations, PwC US

Anirudh Naulay

Anirudh is a New Jersey-based senior manager at PwC with over eleven years of experience in digital quality transformations across the Pharmaceutical and Life Sciences sector. He specializes in digital quality transformations and validation strategy, having led multiple ERP, QMS and other enterprise-wide application validations.

Director, Digital Quality & Validation, PwC US

Sid Pant

Sid is Philadelphia-based director at PwC, specializing in digital quality transformations within the Pharmaceutical and Life Sciences sector. With ten years of experience, he has led validation workstreams for multiple ERP, QMS, and other enterprise-wide digital transformations, managed end-to-end validation activities for clients, and led multiple process transformations to help clients maintain system compliance in a changing regulatory landscape.

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