The primary focus of this workshop is to brief the small, medium and large scale pharmaceutical firms in India filing Abbreviated New Drug Applications (ANDAs) with the FDA. The workshop will address the on-going initiative of Quality by Design (QbD) that can be implemented in the pharmaceutical development of generic drug products. Having this understanding will help both generic applicants and the Agency in bringing quality generic products expeditiously to the market.

In identifying this need for common understanding within Indian pharmaceutical firms, U.S. FDA, DIA and Pharmexcil jointly present the Generic Drug Applications Workshop Series. This workshop will be conducted at four locations across India. See DIA Recommendations below for additonal workshop dates and locations.

You are invited to participate in any one of these workshops and gain experience through a one-on-one interaction with two senior FDA staff members from the Office of Generic Drugs (OGD). They will share valuable information with participants on FDA’s expectations for QbD, and how QbD will impact pharmaceutical development, ANDA submissions and future interaction with the U.S. FDA.

There will be an overview at the start of the workshop followed by three detailed sessions, during which participants will learn the meaning and expectations of terms used, such as “product design” and understanding and process design and understanding. In the afternoon session of the workshop, control strategies will be discussed. At each one-day workshop, FDA staff from OGD will be available for a Q&A session in order to update applicants on recent issues, as requested.
Event Code:12669

Faculty Lane Christensen Science Staff, Office of Generic Drugs FDA, United States Vilayat A. Sayeed Director, Division of Chemistry III FDA, United States