Quality By Design

Quality by Design Project: Recommendations and Toolkit

CTTI Project: Quality by Design

Webinar Presenters:

  • Ann Meeker-O'Connell, Head, Risk Management and External Engagement, Johnson & Johnson BioResearch Quality & Compliance
  • Coleen Glessner, MBA, Quality Expert
  • Martin Landray, Clinical Trials Service Unit & Epidemiological Studies Unit, University of Oxford

*The views and opinions expressed in this video are those of the speaker and do not necessarily reflect the official policy or position of CTTI.

Webinar Objective:

The Quality by Design (QbD) project team presented the QbD recommendations and an introduction to the QbD Toolkit, released June 15, 2015. This web-based Toolkit provides resources for facilitating adoption and real world application of QbD concepts.

Designing High-Quality COVID-19 Treatment Trials

CTTI Project: Quality by Design

 

Webinar Presenters:

  • Pamela Tenaerts (Clinical Trials Transformation Initiative)
  • Janet Woodcock (FDA, CDER)
  • Ed Cox (Regeneron Pharmaceuticals, Inc.)
  • Martin Landray (University of Oxford)
  • John Marshall (WHO Clinical Characterization and Management Working Group, Unity Health CA)
  • Karlin Schroeder (Parkinson's Foundation)
  • Fergus Sweeney (European Medicines Agency)
  • Ann Meeker O'Connell (Vertex Pharmaceuticals)

PDF icon Download Slides

 

 

Accelerating Evidence Generation – Resources for Implementing a QbD Approach to Clinical Trials

CTTI Project: Quality by Design

 

Webinar Presenters:

  • Greg Pennock, EMD Serono
  • David Rodin, Amici Clinical Research
  • Ansalan Stewart, FDA
  • Karlin Schroeder, Parkinson’s Foundation
  • Steve Young, CluePoints

Webinar Resources:

Download Powerpoint Slideset

Resources:

 

FPWR’s Questionnaire Measures Important – But Often Overlooked – Concerns for Prader-Willi Patients and Caregivers

Posted on by Hannah Faulkner

FPWR’s Questionnaire Measures Important – But Often Overlooked – Concerns for Prader-Willi Patients and Caregivers

Get Started

QbD Toolkit: Overview, Learn About QbD , Teach Others About QbD, QbD Principles Document, Exploring the CTQ Factors, Workshop Tools, Adopt QbD, How Others are Using QbD, Get Started

QbD Toolkit Resources: Principles Document, CTTI QbD Recommendations, Key Stakeholders, Maturity Model, Metrics Framework, Case Studies

Getting started with QbD can feel overwhelming, but utilizing our QbD Toolkit will help you. Watch as Coleen Glessner from Pfizer shares her tips on how to get started with QbD within your organization.

Perspectives & Champions

CTTI shares considerations for internal and external perspectives as well as internal champions.

Components for QbD Adoption

This resource describes the four key components needed for a successful QbD implementation.