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PDA 490 Going Deeper than Human Error: Finding More Specific Root Causes to Incidents Involving People

Apr 07, 2022
Dallas, TX

  • Education
  • The Americas

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Program Highlights

Overview

“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.

For more options and/or related training courses, please visit the page(s) below.

PDA Human Factors Training Courses

Agenda

  • Training courses generally run from 8:30 to 16:00 each day. Breakfast and lunch will be provided.

Trainers

James Vesper
James Vesper
ValSource

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.

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

    Roles
    Supervisor, Manager, Specialist

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Travel

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

Hyatt Regency Dallas

300 Reunion Boulevard
Dallas, TX

Make a Reservation
  • Accommodations

    Book within the PDA block and be automatically entered to win a daily treat delivered to your hotel room!

    A block of rooms have been reserved for meeting participants at the Hyatt Regency Dallas. The rate is $249 for single or double occupancy. Guestroom rates are subject to discounted resort fee ($20 per night) and State and Local taxes.

    Reservations must be secured by Friday March 4, 2022. After this date, reservations can be made on a space-and-rate available basis only. Check-in time is 4:00 p.m.; check-out time is 11:00 a.m.

    To make reservations, individuals may click on the reservation link above or call the Hyatt Regency Dallas at +1 (214) 651-1234. Be sure to tell the reservationist that you are with the PDA Meeting to receive the PDA group rate.

    Individual Cancellation

    Please be aware that obtaining and canceling hotel reservations is the responsibility of the meeting registrant. Individuals will be responsible for payment of their own cancellation fees. The cancellation policy is 3 days in advance of arrival date, unless otherwise specified on your reservation information.

  • Amenities

    Please visit the hotel’s website for more information.

How to Get Here

By Air

Dallas/Fort Worth International Airport (DFW) is approximately 20 miles from the Hyatt Regency Dallas and all major carriers service this airport. Dallas Love Field Airport (DAL) is approximately 7 miles from the Hyatt Regency Dallas. Alaska Airlines, Delta and Southwest service this airport. Taxi fares from DFW are approximately $45-50 one way, not including tip. Taxi fares from DAL are approximately $20-25 one way, not including tip. App based rides are available to/from the airport.

By Car

The Hyatt Regency Dallas is located at 300 Reunion Boulevard, Dallas, TX 75207. Valet Parking, operated by PMSI, is available at hotel entrance. In and out privileges for hotel guests only. Self-parking in the outdoor Radish Lot is conveniently located on the north end of the hotel at the intersection of Hotel Street and Reunion Boulevard West. In and out privileges for overnight guests only, operated by PMSI. Self Parking Overnight Guests Includes in & out privileges Daily Guest & Reunion Tower $19 Radish Lot, 0–4 hours | $9 Radish Lot, 4–8 hours | $13 Radish Lot, 8-24 hours | $19 B-Lot, 0–4 | $7 B-Lot, 4–8 hours | $13 B-Lot, 8-24 hours | $19 Valet Parking Overnight Guests |$32 + tax 0–4 hours | $22 4–8 hours| $26 8–24 hours | $32

Other Options

Amtrak: Connected to Hyatt Regency Dallas by way of underground walkway to Union Station. Please call 214 653 1101 for train information. Greyhound: The nearest Greyhound station is located at 205 S Lamar St. Please call 214 849 6831 for bus information. DART Light Rail Service: the hotel is conveniently connected to Union Station on the Red and Blue lines and is also a stop for TRE commuter rail to Fort Worth. Dallas Streetcar: This is a FREE service provided by DART that picks up at Union Station, connected to the hotel, and runs to the Bishop Arts District, one of Dallas' best areas for food, shops and galleries.

Directions

Registration Fees

Early Registration
Registration Type Price By February 21, 2022
Member $899
Non-member $1,079
Gov't/Health Auth./Academic* $699

Regular Registration
Registration Type Price After February 21, 2022
Member $999
Non-member $1,199
Gov't/Health Auth./Academic* $699

* 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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