Design Space Development and Verification
View Presentation *Christine M.V. Moore, FDA/CDER/ONDQA Keywords: Design space is defined in ICH Q8(R2) as “the multidimensional combination and interaction of input variables (e.g., material attributes) and process parameters that have been demonstrated to provide assurance of quality.” Movement within an approved design space can be performed under a firm’s quality system without notification to regulatory agencies. A challenge for the developer, manufacturer and regulatory reviewer is how to establish and verify a design space such that it will continue to provide assurance of quality. This presentation will discuss some strategies for design space development and for maintenance of the design space over the product lifecycle.
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Key Dates
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April 30 - May 22, 2013
Invited Abstract Submission Open -
June 4, 2013
Online Registration Opens -
August 9 - August 23, 2013
Invited Abstract Editing -
August 23, 2013
Short Course materials due from Instructors -
August 26, 2013
Housing Deadline -
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC