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. For example, The CFR - Code of Federal Regulations Title 21 Subpart B_Organization and Personnel Sec. 211.22 talks about the "Responsibilities of the 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…” Also, the European Commission reads, “Where human error is suspected or identified as the cause; this should be justified having taken care to ensure that process, procedural or system-based errors or problems have not been overlooked if present. Appropriate corrective and/or preventative actions (CAPAs) should be identified and taken in response to investigations. The effectiveness of such actions should be monitored and assessed, in line with Quality Risk Management principles.” We at Human Error Solutions have created the simplest and most effective human error reduction program, with 100% effectiveness when fully implemented in different organizations worldwide. This valid scientific model combines qualitative and quantitative methodologies and provides practical tools that would assist your organization in achieving the desired results.
This training will provide the steps that you will be able to implement in a human error reduction program at your site. It includes practical tools, the six steps for implementation, and how to measure effectiveness to continuously improve human reliability at your site.
This training will provide the steps that you will be able to implement in a human error reduction program at your site. It includes practical tools, the six steps for implementation, and how to measure effectiveness to continuously improve human reliability at your site.
Ginette M. Collazo
Ginette Collazo, Ph.D. is an Industrial-Organizational Psychologist with 20 years of experience that specializes in Engineering Psychology and Human Reliability, disciplines that study the interaction between human behavior and productivity. She has held positions leading training and human reliability programs in the Pharmaceutical and Medical Device Manufacturing Industry.Nine years ago, Dr. Collazo established Human Error Solutions (HES), a Florida based boutique consulting firm, where she has been able to position herself as one of the few Human Error Reduction Experts in the world. HES, led by Dr. Collazo, developed a unique methodology for human error investigations, cause determination, CA-PA development …
50+ new Excel features so far this decade
Mindful Communication:The Key to Meaningful Conversations i…
FMLA Compliance in 2025: A Comprehensive Guide & Strategies…
Excel - 10 Key Worksheet Functions to Skyrocket Your Produc…
Managing Toxic Employees: Strategies For Leaders To Effecti…
Hiring and Retaining Employees in this Crazy Economy
Harassment, Bullying, Gossip, Confrontational and Disruptiv…
Project Management for administrative professionals
Excel Power Skills: Master Functions, Formulas, and Macros …
Outlook - Master your Mailbox - Inbox Hero Inbox Zero
Copilot and HR: An Introduction for HR Professionals
California Meal and Rest Breaks: What You Don't Know Can Co…
Bootcamp for New Managers and Supervisors: Develop These Es…
Policy Pops: Navigating DEI in the 2025 Workplace: Strategi…
Emotional Intelligence: Mastering the Emotions of Great Lea…
How To Conduct An Internal Harassment And Bullying Investig…
How to Manage the Legal Landmine of the FMLA, ADA and Worke…
The Importance of the first 5 seconds when presenting
Managing Difficult Employee Conversations
Female to Female Hostility @Workplace: All you Need to Know
How to Write Effective Audit Observations: The Principles f…
FDA Proposes Framework to Advance Credibility of AI Models