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Parenteral Drug Association Connecting People, Science and Regulation ®

Strategies for Reducing Human Error Nonconformances

Nov 02 - Nov 02, 2017 |
Nov 02, 2017 |
PDA Training and Research Institute | Bethesda, MD
  • Education
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Duration:  1 day
Time: 8:30 a.m. - 4:00 p.m.

Despite the industry’s best efforts, human error remains a regular concern in every pharmaceutical job function. This interactive course will explore the reasons behind frequent and persistent human errors in the pharmaceutical industry, and then discuss strategies for reducing this ever-present metric. Participants will review common human errors in pharmaceutical production, packaging, quality control sampling and testing, validation, and documentation. The concept of poka yoke, or mistake-proofing, will be examined. Through the use of examples, case studies, and small group exercises, attendees will brainstorm and create solutions to recurring human error problems, and take home a personalized action plan for implementation back on the job. This course will help attendees think outside the box about creative and successful strategies to reduce human error.

Who Should Attend

Managers and supervisors in production, packaging, quality, research, validation and training, who are responsible for CAPA and nonconformance investigations and/or implementation of human error corrective action, will benefit from this course.


There are no prerequisites; however, a familiarity with root cause analysis may be helpful.

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

  • Identify different types of human errors and the need for targeted corrective actions
  • Discuss the concept of poka yoke and how it is used to reduce human error nonconformances
  • Explain how to empower employees to set personal goals for reducing your own human error nonconformances
  • Describe and implement several creative new strategies for reducing human error nonconformances
  • Create a personalized action plan for corrective action implementation back on the job



On or before September 18, 2017

After September 18, 2017


On or before September 18, 2017

After September 18, 2017

Government/Health Authority/Academic



All rates in US Dollars. REFUND FOR COURSES: If your written request is received by October 2, 2017, 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.

Class Schedule

All lecture courses begin at 8:30 a.m. and end at 4:00 p.m. unless otherwise noted on the confirmation letter or in course information posted on the website or in the course brochures. Courses that are listed with a half day will begin at 8:30 a.m. and end at noon on the last day.

Please arrive at your 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.

A continental breakfast will be served before class beginning 8:00 a.m. Lunch will be provided from 12:00 - 1:00 p.m. Snacks will be provided during the morning break from 10:00 - 10:15 a.m. and the afternoon break from 2:30 - 2:45 p.m.


The course will be held at:

PDA Training and Research Institute
4350 East West Highway, Suite 150
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

Elaine Lehecka Pratt, President, Lehecka Pratt Associates, Inc.

Elaine Lehecka Pratt is president of Lehecka Pratt Associates, Inc., a consultancy specializing in pharmaceutical regulatory compliance training. She is also an Industry Professor in Stevens Institute of Technology’s Graduate School of Engineering and Science program in Pharmaceutical Manufacturing where she is the recipient of the 2016 Provost’s Award for Online Teaching Excellence. An experienced public speaker/technical trainer, she holds a B.S. degree from Ursinus College and a M.B.A. degree from Fairleigh Dickinson University. Before starting Lehecka Pratt Associates in 1986, she worked at Schering-Plough Corporation in production line supervision and as training manager, and served as one of the first presidents of the GMP Training and Education Association, as co-chair of the ASTD Pharmaceutical/Chemical Industry Group, and on the PMA Training and Education Resource Committee. She has published articles in Pharmaceutical Technology, Pharm Tech Japan, Controlled Environments, Journal of Pharmaceutical Innovation, Performance in Practice, and Drug Development and Industrial Pharmacy. She is also a chapter author of Virtual Teams: Mastering the Art and Practice of Online Learning and Corporate Collaboration (Wiley, 2010). Always a popular presenter, she has spoken at national/international meetings of ASQ, ATD, PDA, PMA, GMP TEA, APhS, SME, ISPI, Pharm Tech and Interphex, and served on the planning committees for the PDA and GMP TEA Biennial Training Conferences.

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 #209 | ACPE #0116-0000-17-006-L04-P | 0.6 CEUs
Type of Activity: Knowledge

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.