Errors in GMP Regulated Manufacturing

• Define ‘error’ as it applies to human behavior in GMP-regulated environments
• Explain the relevant industry regulations that relate to errors and their investigation
• Distinguish between skill-based, rule-based, and knowledge-based errors
• Provide examples of errors that can arise in a GMP manufacturing environment
• Explain why ‘human error’ is not a valid root cause
• Outline various approaches for determining root cause(s) of errors
• Explain reactive and proactive approaches to error management

Learner Benefits:

• Understand the Complex Nature of Errors: Learn to distinguish between skill-based, rule-based, and knowledge-based errors, and gain insights into the regulations that govern error investigation in GMP environments.

• Identify and Address Root Causes Effectively: Explore why ‘human error’ is not an acceptable root cause, and discover various tools and methodologies, such as Root Cause Analysis (RCA), to identify underlying issues in work systems.

• Develop Skills in Error Management: Learn how to identify, classify, and manage errors effectively, helping to prevent future incidents and ensure continuous improvement in GMP compliance.

• Enhance Compliance with Industry Standards: Gain practical knowledge of the regulatory requirements surrounding errors and violations, contributing to robust quality systems within your organization.

• Apply Learning Through Scenario-Based Exercises: Reinforce understanding of error classification and management with realistic scenarios, facilitating competent handling and mitigation of errors in the workplace.

    Animations
   Voice Over
    Knowledge Checks
    Assessments
   SCORM/AICC compatible
    Full Screen