Online Webinar 2019 - Use Code EBJUL19 & Get 10% Off

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 thatprocedures can be human engineered, improved and fixed.
Why you should attend:
Procedures are essential for both execution and audits. These should be written for users without missing relevant 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.
Session Highlights
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, 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 leaders and managers
Plant engineering
Compliance officers
Regulatory professionals
Executive management
Manufacturing operations directors
Human factors professionals
Speaker
Ginette M. CollazoPh.D, President, Ginette M. Collazo, Inc.
Dr. Collazo has spent more than 15 years in technical training, organizational development and human reliability. She has worked with Bristol-Myers Squibb, Johnson & Johnson, Schering-Plough, Wyeth and Medtronic, many more 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.
Dr. Ginette M. Collazo obtained her PhD in Industrial/Organizational Psychology from the Interamerican University of Puerto Rico. Ginette has over 15 years of experience in the pharmaceutical industry with the Technical Training, Organizational Development and Human Reliability fields.
Currently she is the president of Ginette M. Collazo, Inc. a firm that works with organizations to improve productivity by helping them identify and implement innovative strategies that will warrant that business objectives and results are met and exceeded. GMC, Inc. specializes, also, in Human Error reduction allowing organizations to achieve savings and reduce/avoid unnecessary costs associated with people’s mistakes.