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

Name: PDA 490 Going Deeper than Human Error: Finding More Specific Root Causes to Incidents Involving People
Start: 2022-04-07
End: 2022-04-07

Apr 07, 2022

Dallas, TX

Education

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The Americas

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Program Highlights

SPECIAL DISCOUNT: Attend this training course for only $899 when you register by 11 March and use campaign code AM22TRAINING.

Health and Safety

The safety and wellbeing of our participants is a top priority for PDA; therefore, we will be implementing the following guidelines for this in-person event:

Vaccination Requirement

Participants, including attendees, exhibitors, trainers, students, staff, guests, contractors, and vendors, must provide proof of vaccination after registering for an in-person event. Accommodation may be offered on a case-by-case basis for any in-person participant who is unable to be vaccinated due to disability or medical condition, or in connection with a sincerely held religious belief or practice, unless otherwise provided under applicable state or local law. Accommodation requests must be made no later than 18 March 2022.

For those registered for the in-person meeting, you will receive a link to upload and verify your vaccine status in early 2022.

Participants that are unable to meet the vaccine requirement or fail to get a PDA-approved accommodation request will not be granted admittance to the event.

Mask Requirement

If mandated by national, state, or local guidelines in effect during the dates of any meeting, PDA will require masks to be worn indoors regardless of vaccination status.

Additional Requirements

PDA will be making decisions on additional precautionary measures closer to the date of the event and in accordance with the latest CDC guidance, local requirements, and hotel policies.

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
PDA Annual Meeting Training Courses

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Agenda

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

Trainers

James L. Vesper

ValSource, Inc.

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. Describe how psychological safety can contribute to better organizational learning and error reduction
4. Develop an implementation plan so individuals and organizations can effectively identify factors and causes of events that are often called “human errors”
5. Apply a variety of approaches and tools that can be used to prevent or mitigate those errors involving people
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

Got a Question? We have answers

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.

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

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].

All prices in Euro (EUR), excluding VAT

For your credit card information safety: Please send your details by fax only

For an easier registration, please note the helpful hints on the registration form

Ways to Register

Online Registration
FAX: +49 30 436 55 08 66
[email protected]

Please remember to log in if you are a member of PDA already!

If you come from a Governmental or Health Authority Institution or from an Academic Organization please contact Ms. Antje Petzholdt before registering. She will verify your status and register you.

All registrations which will involve visa matters will have to be submitted to PDA EU four weeks prior to the start of the event at the latest. For later registrations, PDA Europe will be unable to assist participants in any visa affairs.
All costs incurring in connection with visa affairs shall be borne by registrants. (This applies in particular to costs for submitting documents by courier.)
Potential participants must be clients of UPS shipping agency and submit their UPS customer reference number to PDA EU (together with their registration).
Please contact us if you are entiteld to receive a discount

Antje Petzholdt

Manager Registration, Chapters & Membership
Tel: +49 (0) 30 43 655 08-10
Fax: +49 (0) 30 43 655 08-66
Email

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Tel: +1 (301) 656-5900
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Tel: +49 (0) 30 43 655 08-10
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PDA 490 Going Deeper than Human Error: Finding More Specific Root Causes to Incidents Involving People