Events

Bethesda North Marriott Hotel and Conference Center

North Bethesda, MD

May 4 - 5, 2010

Overview | Sponsorship Form | Agenda | 2010 QbD Workshop Case Study

GPhA is pleased to announce the GPhA/FDA QbD Workshop.

Incorporating Quality by Design (QbD) in product and process development for generic drugs is becoming an increasingly critical component of ANDAs. It is highly recommended that QbD approaches be used as part of product and process development strategies. With the growing importance of Quality by Design approaches during the technical review of an ANDA, it is essential that the generic industry has a clear understanding of the Office of Generic Drug’s expectations. The FDA/GPhA QbD Conference will provide an interactive forum to build a common understanding of the type of information that should be included in ANDAs as part of the QbD paradigm.

Key Conference Objectives Include:

• To identify gaps in the understanding of QbD between OGD and industry
• To build a common understanding of certain key aspects of QbD
• Discuss how QbD can be applied to MR dosage forms

Hotel Information:

Bethesda North Marriott Hotel and Conference Center
5701 Marinelli Road
North Bethesda, MD 20852

To reserve a hotel room, call 800-228-2920. To receive GPhA’s preferred rate, mention the “GPhA QbD Meeting.” A limited number of rooms are available at the preferred rate until Monday, April 19, 2010. After these rooms sell out, or after April 19, rooms are subject to standard hotel rates and availability. GPhA’s preferred rate is only available to registered attendees.

Fees:

GPhA Member: $1550
Nonmember: $1895

Cancellations:

Cancellations must be received in writing either faxed to 703-647-2481 or emailed to jnguyen@gphaonline.org by April 23, and confirmed by GPhA. All cancellations are subject to a $300 processing fee. No refunds after April 23, 2010.