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32784 Conferences

Quality by Design An FDA initiative to Aid companies in the Development of Products and Reduce the Regulatory Burden

Added by Referral on 2011-10-13

Conference Dates:

Start Date Start Date: 2011-11-21
Last Date Last Day: 2011-11-21

Conference Contact Info:

Contact Person Contact Person: Referral
Email Email: referral@complianceonline.com
Address Address: 2600 E. Bayshore Road, Palo Alto, California, 94303, United States
Phone Tel: +1-650-620-3915
Phone Fax: +1-650-963-2556

Conference Description:

In this Webinar, you will learn the origins and rationale for the QbD program, exactly what Quality by Design is and how it might be applied to your operations. With these investments of effort, you will learn what you must provide to the agency and the benefits you might glean from the effort. You will also appreciate why your other submissions have not met the requirements of QbD previously. These benefits work equally well for established products that are currently on the market and those that you plan to commercialize in the future.

Areas Covered in the Seminar:

- The origins of QbD and the reasons why it was implemented?
- What exactly is QbD?
- What the agency is looking for?
- How to assess your product development programs to determine what your return on investment for this program will be?
- How to assess your product development efforts and streamline them to gain maximum benefit from the QbD initiative?
- How to obtain regulatory relief in terms of simpler submissions and less frequent and shorter inspections?
- What the challenges to implementation of QbD are?
Where the successes have been and how it is moving in the industry?
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