101_Human Error Reduction in GMP Manufacturing/Floor

If you work in the GMP-regulated industry, you not only need to address human error deviations because they are an inconvenience, but you must do it because the regulation requires it. The CFR - Code of Federal Regulations Title 21 Subpart B_Organization and Personnel Sec. 211.22 talks about the “Responsibilities of quality control unit.” and it states that “(a) There shall be a quality control unit that shall have the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products, and the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated…” That being said, Human Error is NOT a root cause. Human errors start at the design stage. From procedures, training, and workplace environment, many variables that affect human behavior CAN be controlled, reducing the likelihood of these occurrences. To work with these challenges, it is essential to understand human behavior and the psychology of error, as well as implementing a process exclusively dedicated to investigating and “fixing” these problems.

This course offers practical approaches and models to address human performance issues in GMP-related environments by using a particular methodology to correct, prevent, and avoid reoccurrence of these matters.

Areas Covered:-

• Human Error as the Root Cause
• What is Human Error
• How is Human Error controlled?
• Root Cause Determination
• Types of error
• Human error and training: when and where
• Human error rates and measurement
• Trending and tracking
• Prediction
• CAPA effectiveness
• ChatGPT Integration

Learning Objectives:-

• Understand the psychology of error
• Regulatory requirements in GMP environments for managing human performance deviations.
• Root Cause Analysis and Investigation
• Root Cause Determination Tool
• Establish the Human Error Rate at your site
• Implementing the program
• Metrics and KPI’s
• Artificial Intelligence Integration

Why Should Attend:-

We need to be able to explain human behavior. Did the human fail because of process weaknesses that set them up for failure? Do procedures provide for all information and clearly indicate critical steps and warning or cautions associated with steps? Do systems work for manufacturing, or is it the other way around? These are all tough questions to ask, but most importantly, answer. This training would provide tools that can be implemented and used after this event. These include practical tools. We will discuss human error categories, near root causes, and root causes for these events. We will discuss the latest trends in human error issues in the industry.

Who Should Attend:-

• Training Managers and Coordinators, Manufacturing and Operations Personnel
• Quality Assurance (QA) / Quality Control (QC) Staff
• Process Excellence and Continuous Improvement Professionals
• Compliance Officers
• Plant Engineers and Maintenance Staff
• Regulatory and Legislative Affairs Professionals
• Corporate and General Counsel
• Industrial and Process Engineers