Organizational Strategies for Reducing Human Error in GMP Environments: 4 Informative Webinars

This advanced package training course helps you understand the importance of reducing human errors in GMP related environments and the need for CAPA effectiveness. This program will help executives to recognize the importance of writing procedures to avoid human errors and best formats and content elements for SOPs. Expert speaker Ginette M Collazo also talks about factors and causes of human errors in GMP related environments and provides practical tools for controlling human error in the manufacturing floor.
Instructor: Dr. Ginette M. Collazo
Product ID: PACK70051

CD/Recorded-How It Works:

  • Webinar CD/Recorded will have a series of modules. Our experts have delivered the modules using PowerPoint Presentations
  • Webinar Recording Link or CDs are licensed to be used multiple times at any location with multiple attendants
  • Get unlimited access for Recorded links
  • Free shipment of CDs within 72 hours from the date of purchase
  • Reference materials for Webinar Recording Link/CDs will be mailed to your registered e-mail id

Webinar Topics:

Who will benefit?

  • Training managers and coordinators
  • Operations
  • Manufacturing
  • Plant engineering
  • QA/QC staff
  • Process excellence/improvement professionals
  • Industrial/process engineers
  • Compliance officers
  • Regulatory/legislative affairs professionals
  • General/corporate counsel
  • QA/QC directors and managers
  • Training directors and managers
  • Manufacturing operations directors
  • Human factors professionals
  • Executive management

Webinars included in the Package:

How to Write Procedures to Avoid Human Errors (Duration: 90 Minutes)

This presentation by Ginette Collazo will discuss key topics including content development and formats designed for human error reduction due to procedures. Procedures are 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.

Objectives of the Presentation:

  • Understand the importance of procedures
  • Learn why people refuse to use procedures
  • Learn best formats and content elements for SOPs
  • Learn document hierarchy and different types of procedures based on their use
  • Understand the common Human Errors and deviations related to the use of procedures
  • Understand the reading and writing processes and how people may impact the processes

Creating and Maintaining an Effective and Efficient Technical Training Program (Duration: 90 Minutes)

Training programs have evolved through time. Human reliability or human error is usually attributed to training effectiveness or training program weaknesses/strengths. Even though training is considered the "vaccine for mistakes" training is not responsible for most human error deviations. In order to make sure training programs are effective and can be ruled out as a root cause for human error deviations, we will discuss elements necessary when implementing/improving a training program. We will discuss elements of the training programs like curricula, training management systems, training effectiveness and other important elements of a compliant training program.

Objectives of the Presentation:

  • Learn key elements of the training program in regulated environment
  • List key performance indicators related to training
  • Learn to develop a training program
  • Learn how to measure training effectiveness
  • Learn when training is responsible for human error deviations

Human Error Reduction in GMP Related Environments (Duration: 90 Minutes)

This course offers practical approaches and models to address human performance issues in GMP related environments by using a specific methodology to correct, prevent and avoid re-occurrence of these issues. 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. From procedures, training, and workplace environment many variables that affect human behavior can be manipulated reducing the likelihood of these occurrences. To work with these challenges it is really important to understand human behavior and the psychology of error as well as understand exactly where the systems weaknesses are, so they can be improved and/or fixed.

Objectives of the Presentation:

  • Understand human error: factors and causes
  • Understand the importance: regulatory and business
  • Define the process to manage Human Error deviations
  • Identify Root Causes associated to human error deviations
  • Learn how to measure human error rates at your site
  • Identify what I can do to support human reliability

Tools for Human Error Reduction: Developing Metrics and KPI's (Key Performance Indicators) to minimize Human error rates (Duration: 90 Minutes)

In this course we will discuss tools available to manage and improve human reliability. These tools are practical and quantitative. From Root Cause Analysis, cognitive load, interview guide, and other tools ready for implementation.

Objectives of the Presentation:

  • Learn about human error measurement
  • Learn about tools for measurement
  • Establish key performance indicators
  • Define and measure human error rate, cognitive load, and CAPA effectiveness
  • Identify what I can do to support human reliability
  • Define the process to manage Human Error deviations

Instructor Profile:

Dr. Ginette M. Collazo obtained her PhD in Industrial/Organizational Psychology from the Inter American 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. She has been a guest speaker about these topics in several professional conferences including American Institute for Chemical Engineers Global conference, Center for Chemical and Process Safety, American Society for Quality, California State Lands Commission Prevention First 2010 conference, Interphex PR and NY, FDAnews, among others.

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