Real Life Case Studies in AI/ML

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Speaker : GAURAV WALIA
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When : Wednesday, September 03, 2025
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Time : 01 : 00 PM EST
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Mr. Walia is currently the VP of CSV/CSA/DI, and
Digital Governance, Head of PQE Chicago Office, and Sr. Associate
Partner at PQE Grou.p
Also, he is an Adjunct Lecturer at Temple University, School of Pharmacy, RA/QA Graduate Program.
With
over 28 years of experience in Pharmaceutical/Medical Device and
Consumer Healthcare environment with extensive experience in end to end
processes such as Computerized Systems Validation, Computer Software
Assurance, Data Integrity, Cleaning Validation QMS, SDLC, Agile and
Waterfall Methodologies, Validation and Qualification (within, IT,
Laboratory, Manufacturing for Standalone through Enterprise Systems), IT
Policies and SOP generation, review, revision and approval, IT
Infrastructure Review and Qualification/Validation and
Audit/Documentation, overall Audit/Assessment Execution with GAP
Generation and Remediation, Customer and Vendor Audit and Compliance
Quality Assurance Compliance and Laboratory Analyses. He also recently
has been involved in the areas of Cybersecurity, Machine Learning and
AI.
Mr. Walia has over 100 FDA Audits/Inspections under his belt as well as 3 Major Consent Decree Projects focusing on Computer Systems Validation and Data Integrity, and is also a former Director of R&D, Quality, and IT CSV.
Mr.
Walia is a Member of PDA and ISPE as well as a contributing expert with
publications for KENX, Executive Advisory Board Member for IVT/Informa,
and current Vice Chairman in Chicago for the American Society for
Quality (ASQ)
Real Life Case Studies featuring ML/AI, including Predictive Maintenance, Defect Detection, Environmental Monitoring, CAPAs, etc.
- Demonstration of Foundation of AI/ML
- Demonstration of Real Case Studies in Industry (non-Life Science)
- Demonstration of AI Validation Workflows and Process
- Real Life Case Studies featuring ML/AI in Life Sciences, including:
- Predictive Maintenance,
- Defect Detection,
- Environmental Monitoring,
- CAPAs, etc.
Takeaway Tools
- FDA AI Draft Guidances Discussion
- Global Progress in AI
- Key areas of AI success
- Real examples of how to AI implementation and proof of concept journey
Areas Covered
Real Life case Studies in AI/ML, AI Draft Draft Guidances by FDA and EU AI Act
Who Should Attend
Sr. Manager, Director, VPs, Validation, Quality, IT
Why Should You Attend
People should attend that want to know the latest trends in Machine Learning and Artificial Intelligence. In addition, if you want learn about FDA’s recent Draft Guidance in AI.
You will learn by attending the concept f the EU AI Act.
Don’t miss out to stay up to date on our Industry Trends in ML/AI
Topic Background
Demonstrating the Main concepts of CSB, including FDA regulations like Part 11.
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$199.00
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