Events

Bethesda North Marriott Hotel and Conference Center

North Bethesda, MD

May 4 - 5, 2010

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

GPhA is pleased to announce its partnership with FDA in hosting the first two-day workshop devoted solely for the purpose of fostering in-depth discussion between FDA and the generic industry on Quality by Design for ANDAs.

An unprecedented 70 FDA speakers and attendees have registered for this event underscoring the commitment and importance of this critical, emerging paradigm.

Our 18 top FDA speakers include:

Attendees to this interactive workshop will have the opportunity to meet nearly 70 FDA attendees including OGD staff directly responsible for reviewing your company’s ANDAs.

Why is Quality by Design so important?

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 Drugs’ expectations.

By attending this event, you will gain an 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 develop 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 800-228-9290.

Fees:

GPhA Member: $1550
Nonmember: $1895

Cancellations:

Cancellations must be received in writing either faxed to 202-249-7105 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.

GPhA thanks our Quality by Design Workshop for ANDAs sponsor to date:

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