COURSE DESCRIPTION

OVERVIEW

Most companies still show “human error” as a leading root cause to programs and issues in their organizations – even though it may not be the case.  What if you could take some proactive steps at the organizational level that would address potential situations commonly seen as “human error” before they occurred?  What if your manufacturing organization was built around a “Quality by Design” approach, eliminating human errors and risks?  It’s not has hard to do as you might think, and the benefits are innumerable and measureable.

In this interactive webinar, we’ll utilize a common human performance model to work through examples of what we need to do organizationally to address these areas before they become issues.  We’ll also look at some examples of FDA observations related to these situations as well. Attendees will participate in discussion, brainstorming and problem analysis during the session to learn how to apply the model to their own company/situation and analyze their own situation for improvements that can be implemented – before the next “human error”

LEARNING OBJECTIVES

Attendees will learn:

1. What areas need to be in place to enable people to perform tasks correctly
2. Common problem areas in each portion of the model where organizations often create human error situations
3. Strategies to address those areas proactively, before they become problems
4. Observations from FDA that support the need to ensure these areas are addressed in GMP environments