Organizational Strategies for Reducing Human Error in GMP Environments

Duration: 90 Minutes - Online
Price: $279 - Includes Bonus Handouts!

Course Description:

Most companies still show “human error” as a leading root cause to manufacturing and quality issues in their organizations – even though it may not be the case.  Furthermore, global health authorities increasingly see this as a “lazy” approach to root cause analysis which is commonly reflected in audit observations.  However, the problem of human error still persists, so how can you change your culture of quality and still show regulators that you are mindful of all possible root causes?  Thankfully, there is a better way to change your view of human error…

What if your manufacturing organization was built around a “Quality by Design” approach, eliminating human errors and risks?  It’s not as hard to do as you might think, and the benefits are tangible and measurable.

In this interactive webinar, we’ll utilize a common human performance model to work through examples of what you need to do organizationally to address potential issues before they happen.  We’ll also look at some examples of FDA observations related to these situations, and how a new approach may save you from the same fate.  You will participate in discussion, brainstorming, and problem analysis during the session to learn how to apply the model to your own company/culture before the next “human error” occurs.

During this session, you will:

  • Identify what areas need to be in place to enable people to perform tasks correctly.
  • Recognize common problem areas in each portion of the model where organizations often create human error situations.
  • Determine strategies to address those areas proactively, before they become problems.
  • Review observations from FDA that support the need to ensure these areas are addressed in GMP environments.

Learning Objectives

This course will be of benefit to anyone working in a GMP regulated environment – on a global or domestic scale – that is charged with identifying and addressing sources of human error in GMP operations. This includes leadership, management, and other personnel in quality, manufacturing, engineering, and other regulated functions. This course will be of particular interest to those managing, leading, or working in a training function.

Instructor Bio

Joanna Gallant, a seasoned consultant and industry trainer, is a solutions-driven quality and training professional with nearly 25 years of technical and operational experience in pharmaceutical, biotechnology, tissue culture,  medical device development, and manufacturing environments. Joanna is fluent in a variety of global regulations and standards (including US, EU, PIC/S & WHO GMP; 21 CFR Parts 11, 58, 600, 803, 820 & 1271; ISO 13485, and ICH Q7-10).  She has successfully represented the training function to regulators from around the world, and quickly develops a positive rapport with auditors.

Joanna regularly speaks at industry meetings/conferences and has held leadership positions in the Massachusetts-based BETA organization for the last 15 years, and was asked to join the GMP TEA, Inc. Board of Directors in 2008, where she now serves as an Advisor to the Board of Directors.  Joanna is a co-founder/instructor in Worcester Polytechnic Institute’s Biomanufacturing Certificate Program, and is an Adjunct Professor at the Boston University School of Medicine’s Biotechnology degree program.  Joanna is also a regular contributor to Pharmaceutical Online and other publications on training and compliance topics.

Duration: 90-Minutes - Online

Price: $279 - Includes Bonus Handouts!