Human Errors in GMP Manufacturing and Laboratory Processes

Identification, Correction, and Prevention – Latest FDA Requirements & Common GMP Issues Caused by Human Error

This live training webinar will discuss regulatory requirements for detecting, correcting, and preventing human errors in GMP manufacturing and laboratory processes. Attendees will learn how to build corrective and preventive action (CAPA) systems that are truly effective.

Human error is often cited as a root cause for deviations and quality incidents, yet retraining and SOP rewrites rarely resolve the underlying problems. Many failures trace back not to individuals but to systems, facilities, and operations designed without human factors in mind. This training will show how to uncover true root causes, design meaningful CAPAs, and significantly reduce repeat observations to improve efficiency and compliance.

Learning Benefits

• Recognize why human error is frequently (and incorrectly) designated as a root cause
• Understand why CAPAs are often ineffective
• Probe deeper into contributing system, facility, and operational factors
• Develop true CAPAs that address root causes
• Build efficient, effective CAPA systems to remedy ingrained problems
• Identify and prevent human error during data entry
• Learn the most common GMP issues caused by human error in labs and manufacturing

Regulations Covered

• US CFR 21 Parts 210, 211, and 600 series (Biological Products and Drugs)
• Health Canada regulations, including Annexes 1, 2, 3, and 18
• EMA Eudralex Volumes 1, 2, 3, 4, 9 (EU)
• ICH Quality Series Q1 through Q10 (US, EU, Japan, global)

Who Should Attend

• Quality Assurance and Quality Control Personnel
• Supply Chain and Logistics Managers
• Regulatory Affairs Professionals
• Process Development Scientists and Management
• Manufacturing Management and Scientists
• Project Managers in CMC