Round Table Invited Session On QbD: QbD Filings | AIChE

Round Table Invited Session On QbD: QbD Filings

Chair(s)

Seymour, C., Pfizer

Co-chair(s)

Wu, H., FDA

Round Table Invited session on QbD: QbD filings As FDA continues to facilitate the modernization of regulatory processes related to pharmaceutical products in the 21st Century, Quality-by-Design (QbD) approaches for some of the pharmaceutical process/product development and manufacturing have been discussed intensively over the past few years in various forums. Some real-world case studies have been reported in the public literature. However, a risk-based and science-based approach for QbD filling based on the regulatory guidance and guidelines are barely shared and discussed in the public domain. As a first step, this round table discussion session is intended to address this information gap to the possible extent. Inputs from recognized experts and experienced practitioners in the community across academia, industry, and regulatory agencies in the world will be sought to identify commonality among QbD filing. An in-depth Q&A following the presentations should stimulate innovative research and development in the QbD area, and facilitate the QbD implementation in the pharmaceutical sector.

Presentations

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Paper abstracts are public but to access Extended Abstracts, you must first purchase the conference proceedings.

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Pricing

Individuals

2011 Annual Meeting
AIChE Pro Members $150.00
AIChE Graduate Student Members Free
AIChE Undergraduate Student Members Free
AIChE Explorer Members $225.00
Non-Members $225.00
Comprehensive Quality by Design in Pharmaceutical Development and Manufacture only
AIChE Pro Members $100.00
Food, Pharmaceutical & Bioengineering Division Members Free
AIChE Graduate Student Members Free
AIChE Undergraduate Student Members Free
AIChE Explorer Members $150.00
Non-Members $150.00