US FDA-DIA-Pharmexcil - Generic Drug Applications Workshop Series
Venue: Lemon Tree Hotel
|Event Date/Time: May 07, 2012||End Date/Time: May 07, 2012|
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.
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 FDAâ€™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 â€œproduct designâ€ 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.