If you work in the GMP-regulated industry you not only need to address human error deviations because they are an inconvenience, 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 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, they have been fully investigated…”
Also, the European Commission reads, “Where a 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 actions 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 (HES), have created the simplest and most effective human error reduction program, with 100% effectiveness when fully implemented in different organizations around the world. This valid scientific model combines qualitative and quantitative methodologies and provides practical tools that would assist your organization in achieving 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 …
5 Proven Ways To Engage & Retain Your Team Even During The …
From Awareness to Action: Going Beyond the Law in Preventin…
FDA Compliance and Clinical Trial Computer System Validation
Customer Relationship Management: Strategic Methods to Mana…
Navigating New Paths: Unveiling Your Unique Abilities for a…
Strategic Interviewing & Selection: Getting the Right Talen…
Form 1099 Update 2023: Latest Forms, Rules and Reporting Re…
Amazing (!) AI Tools For Building Your Business
Implementing a Robust Change Control Program - Key Elements…
Project Management for Non-Project Managers - How to Effect…
Excel - Unleashing the Full Potential of New Functions (Exc…
Onboarding is NOT Orientation - How to Improve the New Empl…
How to Conduct Annual Product Reviews to Achieve GMP Compli…
Time Management/Four Functions of Management
Responding to EEOC Discrimination Charges-What's Your Busin…
Harassment, Bullying, Gossip, Confrontational and Disruptiv…
What Business Leaders Need to Know About Cybersecurity Prep…
Motivation - Motivating Yourself & Others
Excel - Power Pivot and The Data Model - Building Advanced …
Understanding Social Security and Optimizing Retirement Inc…
Stop Letting that Difficult Person Ruin your Day - Effectiv…
2023 ADA Accommodation Compliance Requirements
Human Connection Leadership in 3D: Dare. Dream. Deliver.
Winning Conversations: How to Communicate Successfully and …
Performance of Root Cause Analysis, CAPA, and Effectiveness…
Fight Inflation by Optimizing Working Capital with Advanced…
Employee Handbook Requirements for 2023. Includes Updated F…
Using Better Managerial Decision Making - to get great resu…
Empowered Leadership: H.O.P.E. The Spark of Transformation
How to Put Your Best Foot Forward Virtually