Research and Resources

Workshops and Webinars

AHI Webinar – “Question-Based Review – Part III: Sterile Process Validation”

Dates and Times:
February 17, 2011, 10:00am-12:00pm EST (General information on QbR and the eSubmitter as well as sections of the general drug product section of the eSubmitter as it pertains to sterile products)
February 17, 2011, 1:00pm-5:00pm EST (Sterile Process Validation sections of the eSubmitter)

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 third of a three-part series discussing an approach to QbR for animal drugs. Part I focused on drug substance (completed in March 2010), while Part II focused on drug product (completed in July 2010), and Part III covers sterile process validation. Part III is a one day webinar that will address question-based review as formatted in the FDA’s eReview module. This is a practical exercise in which a discussion of common review issues will be addressed for each section of the QBR for a sterile drug substance/product.

Prior to attending the webinar, participants are urged to familiarize themselves with:

Guidance for Industry for the Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products

Guidance for Industry Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice

CVM ONADE eSubmitter: http://www.fda.gov/ForIndustry/FDAeSubmitter/ucm226814.htm

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


Registration:

Please note, registrations will not be accepted after Friday, February 4th.

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 https://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 – QbR – Part III: Sterile Process Validation” 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.