How to Write Error Free and FDA Compliant 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.

Learning 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

Areas Covered in the Webinar:

1. SOP Writing Outline
2. Content
3. The Reason of Procedures
• Regulatory compliance background
• Universal purpose of procedures
4. The Human Perspective
• Human error as a root cause
• The thinking and reading process
• Common mistakes and causes
5. 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

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

Instructor Profile:

Ginette Collazo, PH.D, is a human error and human behavior expert. She has spent more than 15 years in technical training, organizational development and human reliability areas. She has worked with Bristol-Myers Squibb, Johnson & Johnson, Schering-Plough, Wyeth, and has been a consultant with major firms like Abbott, Johnson & Johnson, Perrigo, among many others. She has also implemented human error reduction programs and technology in many small and mid-sized drug and device companies. An active researcher in specialized studies related to human reliability, she is the author of numerous publications on these topics.

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