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04-Apr-2019 - 04-Apr-2019

Human Error Reduction in GMP Related Environments

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. 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 essential to understand human behavior and the psychology of error as well as understand exactly where the weaknesses of the system are so that they can be improved and/or fixed. This course offers practical approaches and models to address human performance issues in GMP related environments by using a particular methodology to correct, prevent and avoid re-occurrence of these matters.

Why should you attend this webinar?

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.

Areas Covered in the Session:

  • GMP regulations on the training topic.

  • Agencies expectations of the training program.

  • Training general aspects.

  • Responsibilities of the training program.

  • Requirements for New employees.

  • Transferred Employees.

  • External Service Providers.

  • Training Events.

  • Skills Qualification Program (OJT).

  • Training Assessment.

  • Retraining.

  • Training Outline/Contents.

  • GMP

  • Technical Training

  • On the Job

  • Training Frequency and Topics.

  • Instructor's Qualifications.

  • Training Curricula.

  • Training Documentation.

  • Review of Training System Effectiveness.

  • Deviations related to performance.

Learning Objectives:

  • Learn essential elements of the training program in a 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.


Who can 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

  • Executive management


Speaker Profile

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.

Register: https://www.compliancekey.us/webinarDetails?industryId=3&webinarid=1402&speakerid=168


Contact Info:

Compliance Key

Email: support@compliancekey.us
Visit: https://www.compliancekey.us/upcoming-webinars
Phone: 717-208-8666