How to Write Error Free and FDA Compliant Procedures

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.

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:

• SOP Writing Outline
• Content
• The Reason of Procedures
• 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

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