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Parenteral Drug Association Connecting People, Science and Regulation ®

Optimizing Human Factors to Improve Data Integrity

Mar 15 - Mar 15, 2019 |
Mar 15, 2019 |
Marriott Marquis San Diego | San Diego, CA
  • Education
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Duration: 1 day
Time: 8:30 a.m. - 4:00 p.m.

Data integrity is a prime focus of regulatory agencies who have recently issued a number of guidance documents on the topic. This highly interactive course will explore the role of data integrity throughout the drug development lifecycle, and will review key highlights of current international regulation and guidance from US FDA, MHRA, PIC/S and WHO. Using case studies, small group exercises, and discussion, attendees will identify the ways that human factors and corporate culture impact data integrity. A model for data integrity improvement will be presented and customized, and attendees will leave with a personalized action plan for implementation back at their facilities.

This course will update attendees on the latest in international regulatory requirements, guidances and best practices, present a model for improvement, and allow attendees to interactively address and brainstorm customized solutions to optimize meeting those requirements on a consistent basis.

Who Should Attend

This course is for anyone who is responsible for the integrity of data, including personal entry or as checker, reviewer, and approver. Those who manage functions that use controlled documents will also benefit from this course.


A basic understanding of Current Good Manufacturing Practices is recommended.

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

  • Explain various concepts and definitions relating to data integrity
  • Describe the key points from regulations and guidance from US FDA, MHRA, PIC/S, and WHO
  • Define and discuss positive and negative effects of human factors and corporate culture on data integrity
  • Customize and use the Data Integrity Improvement Model
  • Create a personalized action plan to improve data integrity for your facility



On or Before January 29, 2019

After January 29, 2019


On or Before January 29, 2019

After January 29, 2019

Government/Health Authority/Academic*


*For Government/Health Authority/Academic nonmembers, online registration is not available and must be faxed in

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

Special Accommodations and Dietary Requirements
If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

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 as soon as possible and will receive a full refund. PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees and exhibitors and may be used to follow up on specific areas of interest after the event. Tape recordings are prohibited at all PDA events. For more information, contact or +1 (301) 656-5900. SUBSTITUTION: If a substitution request is sent by February 13, 2019, no fee will be charged. After February 13, 2019, a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee. REFUND: If a refund request is sent by February 13, 2019, a full refund will be given minus a $200 fee. After February 13, 2019, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to Phone messages are not accepted.

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:

Marriott Marquis San Diego
333 West Harbor Drive
San Diego, CA USA 92101


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 #535 | ACPE #0116-0000-17-022-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.

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