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This presentation by Ginette Collazo will discuss key topics including content development and formats designed for human error reduction due to procedures. Procedures are important for both execution and audits. These should be written for users without missing important information for regulators. Usually procedures have weaknesses that harm productivity, quality and regulatory standing.


  • Understand the importance of procedures
  • Learn why people refuse to use procedures
  • Learn best formats and content elements for SOPs
  • Learn document hierarchy and different types of procedures based on their use
  • Understand the common Human Errors and deviations related to the use of procedures
  • Understand the reading and writing processes and how people may impact the processes


One of the major causes for incurring quality and production losses in many industries is human error. Although it is unlikely that human error can never be totally abolished, many human performance problems could be prevented. Human errors begin at the design stage. Procedures play a vital role in human reliability. Nevertheless, it is extremely necessary to understand human behavior and the psychology of error as well as understand exactly where the instructions weaknesses are, so procedures can be human engineered, improved and/or fixed.


  • SOP writing outline
  • Content development
  • The rational for procedure use
  • Regulatory compliance background
  • Universal purpose of procedures
  • The human perspective
  • Human error as a root cause
  • The thinking and reading process
  • Common mistakes and causes
  • How to create and maintain a procedure
  • Goals of a procedure
  • Good procedure writing practices (Terminology, formats, layouts, mixed cases, steps content, common words, references, branching, conditional steps, the use of precautions, warnings and Cautions)
  • Procedure styles
  • Use of electronic information networks for procedure access


  • QA/QC directors and managers
  • Process improvement/excellence professionals
  • Training directors and managers
  • Plant engineering
  • Compliance officers
  • Regulatory professionals
  • Executive management
  • Manufacturing operations directors
  • Human factors professionals


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 and effectiveness that has been implemented and proven amongst different industries globally. This scientific method has been applied in critical quality situations and workplace accidents.

Ginette is also the author of the book Human Error: Root Cause Determination Model, published in 2008. She is also a speaker at significant events like Interphex, FDAnews Annual Conference, Global Conference on Process Safety, International Conference on Applied Human Factors and Ergonomics, Pharmaceutical Industry Association, and International GMP Conference.

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