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Virtual | Virtual

Event Title
PQRI BTC 2019 Webinar Series: Holistic QbD to Enable Product Quality
October 10, 2019

Scheduled
Date:
October 10, 2019

The Product Quality Research Institute’s (PQRI) Biopharmaceutical Technical Committee (BTC) has launched a webinar series presented by subject matter experts in the pharmaceutical sciences. This is a unique opportunity to learn about the latest research and regulatory trends on a variety of topics and interact with other experts in real-time all over the world without the need for travel. Holistic QbD to Enable Product Quality is the second webinar in this series. 

Summary:  

The quality-by-design (QbD) paradigm has been in existence for a while now, with impact on both industry practices and regulatory reviews. The implementation of QbD has varied across different functions and has influenced how those functions inter-relate. This webinar, with a series of case studies, and the findings of a cross-functional cross-industry team in the PQRI QbD Working Group will highlight the extent, gaps, and opportunities in current practices.

Agenda: 

Welcome and Overview of Webinar
Moderator:  Chris Moreton, Ph.D., FinnBrit Consulting

Current State of QbD Practice and Growth Areas - An update on PQRI QbD WG Discussions
Ajit Narang, Ph.D., Genentech

Evolving QbD trends in Regulatory Filings
Rakhi Shah, Ph.D., US Food and Drug Administration

Case study 1: Addressing Content Uniformity Challenge for Low Strength Entecavir Tablet Formulations 
Divyakant Desai, Ph.D., Bristol-Myers Squibb

Case study 2: Dissolution Rate Justification by PBPK Modeling for Lesinurad Tablets
Xavier Pepin, PharmD, Ph.D., AstraZeneca

Moderated Q&A Session with all speakers

Please register on the PQRI BTC 2019 Webinar Series website.

For more information, please contact Dede Godstrey. 

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