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How to Write Error Free and FDA Compliant Procedures

Duration : 90 Minutes

Dr. Ginette 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 Pharma Read more

This training program will focus on the importance of procedures. Attendees will learn why people avoid procedures and understand common human errors and deviations related to the use of procedures.

Why Should You Attend:

Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. Procedures play a vital role in human reliability. Nevertheless, it is really important 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.

This webinar will discuss practical approaches to address writing rules to reduce the likelihood of procedures.

Course Objectives:

• Understand the importance of procedures
• Learn why people refuse to use procedures
• 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

Course Outline:

• SOP Writing Outline
• Content
• The Reason of Procedures
          o Regulatory compliance background
          o Universal purpose of procedures
• The Human Perspective
          o Human error as a root cause
          o The thinking and reading process
          o Common mistakes and causes
• How to Create and Maintain a Procedure
          o Goals of a procedure
          o Good procedure writing practices (terminology, formats, layouts, mixed cases, steps content, common words, references, branching, conditional steps, the use of precautions, warnings and cautions)
          o Procedure styles
          o Use of electronic information networks for procedure access

What You Get:

• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

• 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

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register


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Subject : How to Write Error Free and FDA Compliant Procedures

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