- October 10, 2019
10:30 AM - 12:00 PM EDT
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.
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.
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.