Data Process Mapping
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Speaker : GAURAV WALIA
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When : Wednesday, October 15, 2025
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Time : 12 : 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)
Using Process Mapping in Data Integrity Governance.
Gaurav Walia, Sr. Global Director and Sr. Associate Partner, PQE Group.
- Demonstration of key issues 483s and Warning Letter Trend in Data Integrity
- Demonstration of Data Process Mapping Assessments Concepts
- Demonstration of Data Process Mapping Tools and Strategies
- Utilization / Latest Industry Trends in Data Process Mapping with Data Integrity Governance
- Integration of data process mapping is a vital component of effective data governance. Aligning pharmaceutical practices with regulatory requirements and enhancing data quality and consistency, ultimately benefits product quality and patient well-being
Takeaway Tools
- FDA Standards for Data Mapping and Real World Data
- FDA Data Integrity and Compliance With Drug CGMP Guidance
- Data Standards for Drug and Biological Product Submissions Containing Real-World Data Guidance for Industry
Areas Covered
Data Process Mapping, CSV, Risk Assesment
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 Data Process Mapping. In addition, if you want learn about FDA’s recent 483 and warning letter trends that help to lead you to a proper Data Process mapping Journey.
You will learn by attending the concept of Data Process Mapping and how to design a better overall Risk Management Program combined with CSV.
Don’t miss out to stay up to date on our Industry Trends Data Process Mapping.
Topic Background
Demonstrating the Main concepts of Data Process Mapping in association with Computer Systems Validation.
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$199.00
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