CTTI invites you to participate in a webinar hosted by the Quality by Design Project Team. During this webinar the project team will present the Quality by Design (QbD) recommendations and provide 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.
Topic: Quality by Design Project: Recommendations and Toolkit
Date: Thursday, July 16th, 2015
Time: 12:00 p.m. – 1:00 p.m. EST (New York, GMT-05:00)
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
To join:
- Meeting Link: Click here
- Meeting Number: 735 985 012
- Meeting Password: ctti
- After you connect to the website, please follow step-by-step instructions for connecting to the audio.
If you prefer to connect to audio only, you can join by phone at:
1-855-244-8681 Call-in toll-free number (US/Canada)
1-650-479-3207 Call-in toll number (US/Canada)
To view recordings of past CTTI QbD webinars, click here.
This webinar is open to the public. We encourage you to forward this invitation to others who may be interested in learning more about the QbD project’s recommendations and Toolkit.
What is Quality by Design?
Quality by Design (QbD) is an approach that focuses effort on those “errors that matter” for the success of the clinical trial. By prospectively examining the objectives of a trial and defining factors critical to meeting these objectives, action can be taken to prevent important risks to these critical factors from negatively impacting outcomes. Understanding what data and processes underpin a successful trial is essential to subsequently identifying and managing important and likely risks to improve quality and outcomes for clinical trials. For more information about QbD, click here.