Data Integrity and Documentation Excellence
Go beyond theory — understand how ALCOA+ appears in real records, how Part 11 applies to electronic systems, and how to design documentation that withstands audits.
Instructor
Charles H. Paul
President, CHP Consulting LLC — Regulatory Compliance & Operational Excellence
What You'll Learn
About the event
About this event
This course addresses one of the most cited areas in inspections: documentation and data integrity. It moves beyond theory to show how ALCOA+ must appear in real records, batch documentation, and electronic systems. Participants will see how shared passwords, backdating, and incomplete entries immediately undermine credibility.
The module clarifies the practical relationship between paper controls and electronic record requirements, including Part 11 fundamentals. By the end, attendees understand how to design documentation systems that naturally withstand audit scrutiny and reduce the risk of integrity-related findings.
This is Module 2 of the Practitioner Course "GMP Master Class for Life Sciences."
Code: SEM37662
Curriculum
Requirements
- QA, QC, Manufacturing, or Regulatory Affairs professionals in life sciences
- Applicable to anyone responsible for documentation, records, or data integrity compliance
Meet Your Instructor
Charles H. Paul
President, CHP Consulting LLC — Regulatory Compliance & Operational Excellence
Charles H. Paul is President of CHP Consulting LLC, a regulatory compliance, operational excellence, training, and technical documentation consulting firm supporting pharmaceutical, biotechnology, medical device, and advanced therapy organizations worldwide. With more than 30 years of experience in regulated manufacturing environments, Charles specializes in helping organizations build sustainable quality systems that support compliance, operational performance, workforce effectiveness, and inspection readiness. His experience includes GMP quality systems, manufacturing operations, technical training development, process validation, deviation management, CAPA systems, operational excellence, documentation systems, and regulatory inspection preparation. Charles has supported organizations implementing new technologies, expanding manufacturing operations, establishing quality infrastructures, and preparing for complex regulatory inspections. He is a recognized author, speaker, and consultant who has delivered numerous webinars and seminars on GMP compliance, quality systems, human performance improvement, technical documentation, inspection readiness, and operational excellence throughout the life sciences industry.
Event Details
Format
Recorded Webinar
Duration
1.5 hours
Certificate
Included
Access
Lifetime
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