confeplanet


How to Write SOPs (Procedures) for Human Error Reduction/ Prevention

All Days
Pharmaceutical | Recorded Webinar | Duration: 90 Minutes
Ginette Collazo

Live webinar instructions will be emailed to you 3 days prior to the event. || The recording, digital download, and full transcript will be available within 48 hours after the webinar.
Description

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 instruction's weaknesses are so that procedures can be human-engineered, improved, and fixed.

Areas Covered:-

  • 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

Why You Should Attend:-

Procedures account for more than 40% of human error events in manufacturing. The majority of regulatory citations are also related to procedures. 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 content development to formats designed for human error reduction due to procedures.

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
Rhanda McKown

Ginette Collazo

Ginette Collazo, Ph. D. is an Industrial-Organizational Psychologist with 20 years of experience specializing in Engineering Psychology and Human Reliability, disciplines that study the interaction between human behavior and productivity. She has held positions leading training and human reliability programs in the Pharmaceutical and Medical Device Manufacturing Industry. Nine years ago, Dr. Collazo established Human Error Solutions (HES), a Florida- based boutique consulting firm, where she has been able to position herself as one of the few Human Error Reduction Experts in the world. HES, led by Dr. Collazo, developed a unique methodology for human error investigations, cause determination, CA-PA development, and effectiveness implemented and proven amongst different industries globally. In addition, this the scientific method has been applied in critical quality situations and workplace  accidents.Ginette Collazo, Ph. D., is the author of the book Human Error: Root Cause Determination Model, published in 2008. She is also a speaker at significant events like Interphex, FDAnews Annual Conference, Global Conference on Process Safety, International Conference on Applied Human Factors and Ergonomics, and of course, Pharmaceutical Industry Association.

Live webinar training is a virtual event that takes place in real time, where a speaker presents information, and participants can interact through a web conferencing platform.
Login to your dashboard and get your Live Instruction. You will also receive a notification via email. Live instructions will be emailed 12 hours before the live webinar.
Recording and Transcript will be available 24 hours after the live date.
Login to your dashboard and download the presentation (PDF).
A Digital Download is a digital file (webinar, video, audio, or other content) that can be downloaded and used without further processing. The download link is valid for 30 days. Please save it to your local storage for lifetime access. This link is unique to you and should not be shared.
Login to your dashboard and click on Digital Download. Download instructions will also be sent via email.
A transcript is a written record of the spoken words in a webinar, including presenter content and participant questions. It can be accessed within 30 days.
Login to your dashboard and download the transcript (PDF). Download instructions will also be emailed. The transcript is available for 30 days.
An on-demand session is a pre-recorded webinar that can be watched anytime with 30 days’ access.
Login to your dashboard and watch the recording. Instructions will also be emailed. Access is valid for 30 days with unlimited views.
Login to your dashboard and download the Invoice (PDF). A confirmation email will also be sent once the order is confirmed.
You can download the registration form or request a call.
Login to your dashboard, go to My Profile, and change your password.