Product Details
Most regulatory citations are related to procedures. And procedures account for more than 40% of human error events in manufacturing. By improving your SOPs, you’ll minimize both human error and regulatory citations.
How do you go about it?
Human Error Solutions’ CEO, Ginette Collazo, Ph.D. — an industrial-organizational psychologist and one of the world’s few human error reduction experts — will explain how to write and get SOPs that minimize human error.
She’ll help you understand exactly where your instructions’ weaknesses are and how you can improve them, reducing the likelihood of human error.
Presentation Takeaways:
- How to prepare an outline and develop world-class SOPs
- The interrelationship between SOPs, quality and regulatory compliance
- Why human error is a root cause for lack of quality and how to minimize it
- Common mistakes and causes of human error
- How to create and maintain a procedure that minimizes human error
- Good procedure writing practices: terminology, formats, layouts, mixed cases, steps content, familiar words, references, branching, conditional steps and the use of precautions, warnings and cautions
- Use of electronic information networks for procedural access
While human error may never be eliminated completely, you will come away with clear guidance to help you write and have SOPs that categorically minimize such issues to avoid human error events and regulatory citations.
Meet Your Presenter
Ginette Collazo, Ph.D. is an industrial-organizational psychologist with 20 years of experience. She focuses on Engineering Psychology and Human Reliability, disciplines that study the interaction between human behavior and productivity, and has become one of the world’s few Human Error Reduction Experts. Dr. Collazo has led many training and human reliability programs in the pharmaceutical and medical device manufacturing industries. Nine years ago, she established Human Error Solutions (HES), a Florida-based boutique consulting firm. With Dr. Collazo as CEO, HES developed a unique methodology for human error investigations, cause determination, CAPA development and effectiveness that has been implemented and proven among different industries globally. This scientific method has been applied in critical quality situations and workplace accidents. She wrote the book Human Error: Root Cause Determination Model, published in 2008. Dr. Collazo is also a speaker at significant events, including: Interphex, FDAnews Annual Conference, Global Conference on Process Safety, International Conference on Applied Human Factors and Ergonomics, Pharmaceutical Industry Association and GMP International Conference.
Who Will Benefit
- QA/QC Directors and Managers
- Process Improvement/Excellence Professionals
- Training Leaders and Managers
- Plant Engineering Personnel
- Compliance Officers
- Regulatory Professionals
- Executive Management
- Manufacturing Operations Directors
- Human Factors Professionals