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Introduction to Quality by Design
Have you wondered what quality in clinical trials really means? The ICH E8R1 presents us with current concepts to achieve ‘Fit for Purpose' data quality as an essential consideration for all clinical trials. The quality of the information generated should be sufficient to support good decision making. It is preferable to build quality into a study and site plan over implementing quality control measures at the site after the fact. This advance planning is known as Quality by Design. Join us for an introduction to basic QbD concepts.

Target group
Intermediate level research team staff and QA personnel

Pre-Requisites
CQI or CAPA training is helpful but not necessary

Learning Objectives
The learner will:
• Recognize basic terms and terminology related to ‘Quality by Design’
• Understand the principles of QBD and association with continuous quality improvement (CQI) and risk management (RM) at the site level.
• Will recognize the shift from quality control (QC) to CQI.

Hosted by Jean Smart

Mar 30, 2022 12:00 PM in Vancouver

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