COURSE ID 2607

Effective Approach to Human Error Reduction

Investigations, Root Cause Determination and CAPA Effectiveness

AVAILABLE ON-DEMAND
Duration: 90 Minutes
Course Instructor

Ginette Collazo, Ph.D.

Price
$ 295
Discounts: We offer a 10% group discount when you register 2 or more attendees (up to 10). Contact us for groups over 10.

Course description

View Course Outline

In GMP regulated industries, it is not enough to address human error deviations as an inconvenience; it is a regulatory requirement. The quality control unit is responsible for ensuring that errors are fully investigated and prevented as per the Code of Federal Regulations (21 CFR 211.22). However, human error is not a root cause but rather a result of various variables that affect human behavior, which can be controlled through design, procedures, training, and workplace environment. Understanding human behavior and the psychology of error is crucial, and implementing a dedicated process to investigate and resolve these issues is essential.

Our 90-minute accredited training course provides practical approaches and models to address human performance issues in GMP environments. We will discuss a methodology to correct, prevent, and avoid the recurrence of these issues, providing you with practical tools that can be implemented in your workplace. The course will cover human error categories, near root causes, root causes, and the latest trends in human error issues in the industry.

Upon completion of this course, you will be able to:

  • Explain the psychology of error
  • List the regulatory requirements in GMP environment for managing human performance deviations
  • Describe Root Cause Analysis and Investigation
  • Use Root Cause Determination tools
  • Establish the Human Error Rate at your site
  • List the steps to implementing the Human Error Reduction Program
  • Use proper metrics and KPIs
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This online training has been designed for professionals working in GMP regulated manufacturing facilities including Pharmaceuticals, Medical Devices, Biologics, Food and Nutrition. In addition, this training will be worthwhile for any other organization that has employees executing activities in which they can make mistakes (ALL).

Personnel holding positions in the following areas will benefit greatly from this training:

  • Training Managers and Coordinators
  • Operations
  • Plant Engineering
  • Process Excellence/Improvement Professionals
  • Industrial/Process Engineers
  • Compliance Officers
  • Regulatory/Legislative Affairs Professionals
  • General/Corporate Counsel
  • QA/QC Staff
  • Manufacturing

Course Instructor

Ginette Collazo, Ph.D.

Industrial-Organizational Psychologist and CEO Human Error Solutions (HES)

Ginette Collazo, Ph.D.’s Courses

Accreditation

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