Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar

Join us for a webinar on November 10 for a discussion of the webinar

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

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.

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.

Webinar Takeaway

  • 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.

Industries who can attend

This 90-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.

Faculty Ginette M. Collazo

Ginette Collazo, Ph. D. is an Industrial-Organizational Psychologist with more than 20 years of experience specializing in Engineering Psychology and Human Reliability. These disciplines 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.

More than ten 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 the world. HES, led by Dr. Collazo, developed a unique methodology for human error investigations, root cause determination, CA-PA development, and effectiveness that has been implemented and proven amongst different industries globally. This scientific method has been applied to 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, the Pharmaceutical Industry Association. 

Faculty Ginette M. Collazo

Choose a Purchase Options

$289

Recorded Access - 6 month Access

For 1 Location Only

You'll have access for an archived recording of the entire 90-minute webinar, including the Q&A period. You can log in any time of day or night. You'll also receive all presentation materials, plus an audio recording and transcript for the entire session. Delivery is approximately 48 hours after the session

$389

Training DVD

Multiple User Access

Within 48 hours delivered - Lifetime Access ,Audio recording of a webinar and reference manual delivered by download. Listen anytime on any compatible device.