AHI

AHI Webinar - "Question-Based Review - Part II: Drug Product"

Dates and Times:
July 8, 2010, 11:00am-1:00pm EDT (Overview of QbR format and QOS for Drug Product)
July 19, 2010, 10:00am-12:00pm EDT (Session I: Capsule Breakout)
July 19, 2010, 1:00-3:30pm EDT (Session II: Type A Breakout)

Cost:
Free

Summary:

Question-Based Review (QbR) provides a general framework for a science- and risk-based assessment of product quality in the chemistry, manufacturing and controls (CMC) submission. The QbR format is a series of questions, focusing on critical pharmaceutical quality attributes, and follows the ICH Common Technical Document (CTD) Quality Overall Summary (QOS). It is an important tool to make the submission preparation and review process more efficient. QbR was first developed in 2005 by the Office of Generic Drugs in the Center for Drug Evaluation and Research and the Center for Veterinary Medicine (CVM) has adapted the QbR concept for animal drugs.

This workshop is the second of a three-part series discussing an approach to QbR for animal drugs. Part I focused on drug substance (completed in March), while Part II will focus on drug product and Part III will cover sterile process validation. Part II is divided into a two-day webinar. The first day will provide an overview of the QbR format and the QOS for drug product. The second day will give attendees the opportunity to have questions answered and to participate in mock exercises during breakout sessions.

Who Should Attend:
Regulatory Affairs Professionals
CMC Professionals
Master File Holders
Drug Product Sponsors

Registration:

Please note, registrations will not be accepted after Thursday, July 1st.

Register Online - Please read all instructions before beginning to register.
If you are registering multiple people from your company for the first time, please contact Patrick Krieger at (202) 637-2440. Please register each person individually, even if you plan on calling in as a group.

Using Internet Explorer, go to http://ecommerce.ahi.org.
Create an account or Log on using your existing account.
- NOTE: This is a separate website from the AHI Members website, so your existing username and password will be different.
- If you have not registered before, you will need to create an account by selecting "Create an Account" and following the steps outlined. For more information, please view our step-by-step instructions by clicking here.
Select "View and register" for events.
Select the "AHI Webinar - Question-Based Review - Part II: Drug Product" event button.
Click "Register" tab in the top right corner.
You may register yourself or someone else from your company.
When you reach the "Functions" tab, check each box to register for the sessions you plan on attending.
You will be asked two general questions regarding the webinar.
Once you receive the Summary page, click “Next" two times to continue through and "Submit Order". An Event Registration Confirmation email will be sent to you after you complete the process. If you do not receive the email, you are not completely registered.
Call in numbers and information will be emailed to participants no later than one day prior to the event.

Questions:

For questions about this event, contact Sam Veluvolu at AHI.