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Going Deeper than Human Error: Finding More Specific Root Causes to Incidents Involving People

Jun 21, 2019
Bethesda, MD

  • Education
  • The Americas


“Human error” is one of the most commonly – and inappropriately – given reasons for unwanted events in the pharma and biopharma industry, even with the pushback from regulatory authorities around the world. Errors involving people do occur, but there are models and approaches that can be used to delve deeper and uncover root, contributing, and proximal causes.

In this one-day training course, participants will examine regulatory expectations regarding investigations where people are involved in the deviation, models and tools used in the transportation industry. They will also learn how the brain and certain actions can set up a person to make a mistake.

During the training course, participants will be able to explore and use different models that are effective in determining what caused or contributed to the category of human error events. Participants can take these models and tools back to their job to use and share with others. Successful application of these models and tools will contribute to finding better and more creative corrective actions and preventive actions, thereby reducing these often-recurring events. Participants will be asked to read in advance an article about an aviation incident which will be used as one of several case studies and activities.


  • An agenda will be provided on the first day of the training course.


James Vesper
James Vesper

Additional Information

  • Learning Objectives

    Learning Objectives

    1. Analyze an unwanted event to determine the factors and causes that contributed to the event
    2. Discuss the regulatory expectations regarding events that are considered to be human errors
    3. Develop an implementation plan so individuals and organizations can effectively identify factors and causes of events that are often called “human errors”
    4. Apply a variety of approaches and tools that can be used to prevent or mitigate those errors involving people
  • Who Should Attend

    Who Should Attend

    This training course is intended for professionals who are involved in investigations and CAPA for sterile drug manufacturing.

    Manufacturing, Quality Assurance, Quality Control, Packaging, Facilities, Engineering, Technical Support

    Supervisor, Manager, Specialist

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PDA Training and Research Institute

4350 East West Highway, Suite 110
Bethesda, MD

How to Get Here

By Air

The Washington/Bethesda area is serviced by the following airports: Ronald Reagan National Airport (DCA), Washington Dulles International Airport (IAD), and Baltimore Washington International Thurgood Marshall Airport (BWI).

By Car

There is a parking garage located at the training course location. The fee is $12/day. Please do not leave your car in the parking garage past 6:00 p.m. as both the building and parking garage access doors are locked.

Other Options

Metro – Ride the Red Line of the Metro and depart at Bethesda station. It is a 5-minute walk from Bethesda station to the training course location.

Amtrak – Ride Amtrak and depart at Union Station. From Union Station, ride the Red Line of the Metro and depart at Bethesda station. It is a 5-minute walk from Bethesda station to the training course location.


Registration Fees

Early Registration
Registration Type Price by May 03, 2019
Member $1,259
Non-member $1,511
Gov't/Health Auth./Academic* $839

Regular Registration
Registration Type Price after May 03, 2019
Member $1,399
Non-member $1,679
Gov't/Health Auth./Academic* $839

* For this member type or discount, online registration is not available, please contact [email protected].

Group Registration Discount: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

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CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].


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