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Parenteral Drug Association Connecting People, Science and Regulation ®

Investigating Human Factors to Correct Operator Errors - New Course

Feb 28 - Feb 28, 2018 |
Feb 28, 2018 |
PDA Training and Research Institute | Bethesda, MD
  • Education
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Duration: 1 day
Time: 8:30 a.m. - 4:00 p.m.

Investigating human error usually begins with root cause analysis, understanding why the error occurred, and generating corrective actions to fix the problem. But when repeat errors happen, we question the robustness of our CAPA process. As investigators, we need to understand how the error occurred first before understanding why it happened, and then align corrective actions that map back to the root cause. The course will have interactive exercises and group activities to cover these content sections: Training Root Cause Analysis, New View of Human Error, 11 System Interfaces as Factors, and Corrective Actions Aligned with Human Error Categories.

Takeaways include:

  • Classifying the type of human error to provide guidance for better alignment of corrective action
  • Determining when the root cause is not a training issue, examining system precursors, and identifying barriers for management to improve or remove
  • Developing an effectiveness check statement for each corrective action to ensure appropriateness, feasibility and realistic expectations for a successful outcome (no repeat incidents)

Who Should Attend

This course is designed for professionals who are responsible for investigating human errors and those who are tasked with conducting CAPA investigations. Additionally, Quality Assurance and Quality Systems staff who are tasked with CAPA close-out tracking and other effectiveness checks will benefit from taking this course.


Familiarity with Root Cause Analysis and CAPA Investigations is highly recommended.

Upon completion of this course, you will be able to:

  • Demonstrate conducting a training root cause analysis
  • Distinguish between hindsight bias and new view of human errors
  • Examine 3 sets of human errors that can influence successful corrective actions
  • Identify system linkages as potential enablers and barriers
  • Apply decision making criteria for implementing corrective actions



On or before January 15, 2018

After January 15, 2018


On or before January 15, 2018

After January 15, 2018

Government/Health Authority/Academic



All rates in US Dollars. REFUND FOR COURSES: If your written request is received by January 29, 2018, you will receive a full refund less a $200 processing fee. After that time, no refunds will be approved. COURSE CANCELLATION: PDA reserves the right to modify the material or instructors without notice, or to cancel an event. If an event must be cancelled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancellation. For more details, contact PDA at or +1 (301) 656-5900.

General Course Information

Please arrive at the course location approximately thirty minutes before the start of the course to sign in. Please be sure to bring your confirmation letter as proof of registration. PDA will not allow persons to attend a course without payment, or guarantee of payment.

Breakfast will be served thirty minutes before the class begins. Lunch will be provided between 12:00 - 1:00 p.m.


The course will be held at:

PDA Training and Research Institute
Bethesda Towers
4350 East West Highway, Suite 110
Bethesda, MD 20814 USA

Recommended Hotel

Hilton Garden Inn Bethesda
7301 Waverly Street | Bethesda, MD 20814 | 0.3 miles from PDA
(301) 654-8111


For more information, please contact:

Stephanie Ko
Senior Manager, Lecture Education
Tel: +1 (301) 656-5900 x151

Vivian Bringslimark, President, HPIS Consulting, Inc.

Vivian Bringslimark has 29 years of Education, Life Sciences Industry experience and Consulting engagements enabling her to provide human performance consulting services for improving people strategies. Her two core competencies are Instructional Systems Design with a focus on Adult Learning Principles and integrating Training Solutions with key Performance and Quality Systems. Vivian holds a M.A. in Adult Education from Teachers College Columbia University and a M.S. in Educational Computing from IONA College. She currently serves as Advisor to Board of Directors for the GMP Training and Education Association and is an active Mentor for SE FL Chapter of ATD.

Continuing Education for Pharmacists

ACPE PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:

PDA #534 | ACPE #0116-0000-17-021-L04-P | 0.6 CEUs
Type of Activity: Application

Continuing Education for Professional Engineers

New Jersey

PDA is an approved provider by the New Jersey State Board of Professional Engineers and Land Surveyors to offer courses to New Jersey Professional Engineers for Continuing Professional Competency (CPC) credit. Following the full participation in this course, participants will receive a Certificate of Accomplishment specifying the number of CPC credits that may be awarded. This certificate can be submitted as verification of completion to the Board for license renewal.

The credit value of this course is 6 CPC credits.

North Carolina

PDA is recognized by the North Carolina Board of Examiners for Engineers and Surveyors as an Approved Sponsor of Continuing Professional Competency (CPC) activities for Professional Engineers licensed by North Carolina. To receive a Certificate of Accomplishment specifying the number of Professional Development Hours (PDHs) that may be awarded, course participants must request the North Carolina Board of Examiners evaluation form from PDA staff. This form must be completed onsite at the conclusion of the course and returned to PDA staff.

The credit value of this course is 6 PDHs.