2020 - How to Write Error Free and FDA Compliant Procedures

Topic How to Write Error Free and FDA Compliant Procedures
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Overview:
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be 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 essential to understand human behavior and the psychology of error as well as understand exactly where the instructions weaknesses are so that procedures can be human engineered, improved and fixed.
Areas Covered in the Session :
SOP writing outline
Content development
The rationale 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, familiar words, references, branching, conditional steps, the use of "Precautions", "Warnings" and "Cautions,"
Procedure styles
Use of electronic information networks for procedure access.
Speaker:
Dr. Ginette M. Collazo is Keynote Speaker at ComplianceKey. She is Nine years ago she established Ginette M. Collazo, LLC. A USA based boutique consulting type that provides services in very specialized areas. Dr. Collazo is one of the few Human Error Reduction Experts in the world. Her firm created a methodology for human error investigations, root cause determination, CA-PA development, and effectiveness, and it as been implemented around the world. Ginette has also applied the methodology in complex scenarios and disasters, like the BP oil spill, offshore drilling, Navy, Chevron explosion investigation, and other industries besides GMP regulated environments.
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