Optimizing Human Factors to Improve Data Integrity

Bethesda, MD
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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.

This training course will help you 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. During this training course, 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. Using case studies, small group exercises, and discussion, attendees will identify the ways that human factors and corporate culture impact data integrity.

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

PDA Human Factors Training Courses

  1. Explain various concepts and definitions relating to data integrity
  2. Describe the key points from regulations and guidance from US FDA, MHRA, PIC/S, and WHO
  3. Define and discuss positive and negative effects of human factors and corporate culture on data integrity
  4. Customize and use the Data Integrity Improvement Model
  5. Create a personalized action plan to improve data integrity for your facility
Event Location
PDA Training and Research Institute
4350 East West Highway, Suite 110, Bethesda, MD Get Directions

Contact

Program Inquiries
Tel: +1 (301) 656-5900
Exhibition/Sponsorship Inquiries
David Hall
Tel: +1 (240) 688-4405
Training Course Inquiries
Tel: +1 (301) 656-5900
Registration Customer Care
Tel: +1 (301) 656-5900

Standard Pricing

Standard Member Price

$1,399

GovernmentMember Only

$979

Health AuthorityMember Only

$979

AcademicMember Only

$979

Non-Member

$1,679

See Qualifying Criteria for Member Types.

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].

Day 1

An agenda will be available soon. Training courses generally run from 8:30 to 16:00 each day. Breakfast will not be provided, but lunch will be provided.

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.

PDA Training and Research Institute

4350 East West Highway, Suite 110
Bethesda, MD , USA

The following hotels are located near the training course location:

Hilton Garden Inn
7301 Waverly Street
Bethesda, MD 20814

Hyatt Regency Bethesda
One Bethesda Metro Center
Bethesda, MD 20814

Residence Inn Marriott Bethesda Downtown
7335 Wisconsin Avenue
Bethesda, MD 20814

DoubleTree by Hilton Hotel Bethesda
8120 Wisconsin Avenue
Bethesda, MD 20814


Please visit the hotel’s website for more information.

How to Get Here
By Air

The Washington/Bethesda area is serviced by the following airports: Ronald Reagan National Airport (DCA), Washington Dulles International Airport (IAD), and Baltimore Washington International Thurgood Marshall Airport (BWI).

By Car

There is a parking garage located at the training course location. The fee is $12/day. Please do not leave your car in the parking garage past 6:00 p.m. as both the building and parking garage access doors are locked.