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How to write error free procedures and comply with GMP regulations

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How to write error free procedures and comply with GMP regulations

Speaker : Ginette M. Collazo, Ph.D.


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.

  • 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

Procedures are very 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. We will discuss from content development to formats designed for human error reduction due to procedures.

  • 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 Click Below Link For Registration:

https://www.demystifiedsolutions.com/trainingDetails/How-to-write-error-free-procedures-and-comply-with-GMP-regulations-DEMY050130


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