January 25 2008, at 02:31 PM Eastern Standard Time
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The Williamsburg Group, LLC - Comment
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Title: The Williamsburg Group, LLC - Comment
Abstract: Russell Madsen, The Williamsburg Group, LLC - Section 211.113(b) has been amended to require validation of all aseptic processes. This codifies a requirement for which currently there is no means to comply. Media fills do not validate aseptic processes.
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Attachments:
The Williamsburg Group, LLC - Comment
View Attachment:Comments
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