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How to Write SOPs for Human Error Reduction
- SOP writing essentials: Outlines and structure
- Effective content development for user-centric procedures
- Understanding the regulatory framework for procedural compliance
- The universal purpose and goals of SOPs
- Incorporating the human perspective into SOP design
- Human Error as a root cause: Identifying and mitigating procedural weaknesses
- Insights into the thinking and reading process to improve clarity
- Common procedural mistakes and how to avoid them
- Best practices for good procedure writing: Terminology, layouts, conditional steps, and warnings
- Maintaining and updating procedures for continuous improvement
- Leveraging AI and digital tools for SOP development and access
Overview of the webinar
Human error is one of the leading causes of quality and production losses across regulated industries. While completely eliminating human error may be unrealistic, many performance problems can be mitigated through better SOP design. Procedures must be written with a clear understanding of human behavior, cognitive processes, and error psychology to identify and correct weaknesses.
This webinar focuses on human-engineered SOPs that enhance human reliability, improve productivity, and meet regulatory standards.
Who should attend?
This training is designed for professionals from GMP-regulated and other compliance-driven industries, including:
- QA/QC Directors and Managers
- Process Improvement/Excellence Professionals
- Training Leaders and Managers
- Plant Engineering Teams
- Compliance Officers
- Regulatory Professionals
- Executive Management
- Manufacturing Operations Directors
- Human Factors Specialists
Why should you attend?
Procedures account for over 40% of human error events in regulated industries, including pharmaceutical, medical device, food, cosmetics, and other GMP environments. Regulatory citations often link directly to procedural weaknesses. Effective procedures are critical not only for execution but also for audits and compliance.
This training will teach you how to develop and write SOPs specifically designed to reduce human error. Learn how to balance user-friendly design with regulatory requirements, ensuring procedures support productivity, quality, and compliance goals.
Faculty - Dr.Ginette Collazo
Ginette Collazo, Ph. D. is an Industrial-Organizational Psychologist with more than 20 years of experience specializing in Engineering Psychology and Human Reliability. These disciplines 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.
In 2009, Dr. Collazo established Human Error Solutions (HES), a US-based boutique consulting firm. She has positioned herself as one of the few Human Error Reduction Experts worldwide. HES, led by Dr. Collazo, developed a unique methodology for human error investigations, cause determination, CA-PA development, and effectiveness implemented and proven amongst different industries globally. Furthermore, this scientific method has been applied in critical quality situations and workplace accidents. A GMP expert also has a Keynote Speaker at significant events worldwide.
Ginette Collazo, Ph. D., is the author of several books, “Including Human Error: Root Cause Determination Model” and “Mission Matters: World Leading Entrepreneurs Reveal their Top Tips to Success.”
Also, she is the host of The Power of Why Podcast. A show about human behavior in the workplace and critical thinking.