In an increasingly digital and regulated environment, effective data governance is not optional—it's foundational. This webinar explores how data process mapping, when integrated with Computer Systems Validation (CSV), enhances your organization's data integrity, regulatory compliance, and risk management strategy. You will learn the principles of process mapping, how to assess vulnerabilities, and how to align your practices with FDA expectations under 21 CFR Part 11 and Part 820. Through real-world examples and key 483/Warning Letter insights, this session will equip you with tools and techniques to build a strong, auditable data integrity governance framework.
Why You Should Attend:
Data process mapping is a powerful tool to uncover data flow gaps, prevent integrity breaches, and prepare for regulatory audits. With regulatory bodies like the FDA tightening scrutiny on data governance and issuing more 483s and warning letters, understanding how to proactively map, assess, and govern data is more critical than ever. This webinar will help you decode industry trends, avoid common pitfalls, and build a resilient compliance strategy. You'll walk away with a clear methodology to integrate data mapping with your CSV and Quality Systems.Course Content
- Learn the core principles of data process mapping and its role in Data Integrity Governance.
- Review FDA’s latest 483 and warning letter trends related to data integrity failures.
- Understand how to use process mapping to strengthen Computer Systems Validation (CSV).
- Explore tools and techniques for mapping data flows, identifying weak points, and mitigating compliance risks.
- Align your data management practices with FDA guidance, including 21 CFR Part 11, Part 820, and CGMP requirements.
- Implement a risk-based approach to data process mapping within your Quality Management System (QMS).
- Evaluate real-world case studies and strategies for proactive compliance.
- Use industry-supported standards for submissions involving real-world data and digital systems.
Speaker
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 36 years experience in U.S. FDA-regulated industries, 22 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files, CAPA systems and analysis.He’s held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. He writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA.
Who Should Attend
- Quality Assurance Teams
- Quality Control Teams
- IT and Data Governance Teams
- Validation and CSV Teams
- Regulatory Affairs Specialists
- Risk and Compliance Officers
- Pharmaceutical and Biotech Managers
- Clinical Data and Informatics Professionals
- Process Excellence / Business Transformation Teams
