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 …
Human Factors Usability Studies Following ISO 62366 and FDA…
Polish your Presence on Linkedin - The Powerful Profile
Marketing to Medicare or Medicaid Beneficiaries - What You …
Leveraging Artificial Intelligence in HR
Bootcamp for New Managers and Supervisors: Develop These Es…
Utilizing A Proven Process When Conducting Sensitive, Inter…
Understanding and Analyzing Financial Statements
The Importance of Storytelling in Project Management
Understand the Different Contexts in DAX, The Filter Contex…
HR Metrics and Analytics 2025 - Update on Strategic Plannin…
Leading a Project and Team in Stressful Times: Supporting y…
Defensive Documentation: Protecting Your Organization from …
Copilot and HR: An Introduction for HR Professionals
Power Bi - Turn Bad Data Into Great Data In Minutes
OSHA Reporting: What are OSHA's Reporting Requirements?
Onboarding is NOT Orientation - How to Improve the New Empl…
Establishing Appropriate Quality Metrics and Key Performanc…
Basic Accounting and Finance for Human Resources Profession…
FDA Audit Best Practices - Do's and Don'ts
How to Write Effective Audit Observations: The Principles f…
EBIT/EBITDA - Understanding Your Profit and Loss Statement-…
Controller Challenges in Changing Times: New Roles as Strat…
Handbook Overhaul 2026: Compliance, OBBB Act & Beyond
FDA Technology Modernization Action Plan (TMAP) and Impact …
Stress, Change And Team Resilience Through Humor: An Intera…
How to Prepare For and Host a FDA Inspection and Respond to…
The Importance of the first 5 seconds when presenting
Excel Spreadsheets; Develop and Validate for 21 CFR Part 11…
From Chaos To Calm: How to Eliminate Drama and Boost Workpl…
Sunshine Act Reporting - Clarification for Clinical Research
Managing Toxic Employees: Strategies For Leaders To Effecti…
Do's and Don'ts of Documenting Employee Behaviour, Performa…
Dealing With Difficult People: At Work & In Life
Harassment, Bullying, Gossip, Confrontational and Disruptiv…