Jeanne Moldenhauer

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Jeanne Moldenhauer is Vice President of Excellent Pharma Consulting, Inc. 404 Washington Blvd, Mundelein, IL 60060 (USA). jeannemoldenhauer@yahoo.com
Tel. +1 847 837 8191

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Review of FDA Warning Letters

Jeanne Moldenhauer
April 1st 2011

The author reviews Warning Letters issued between 2000 and mid-2010 for aseptic processing and non-sterile processing, and determines how many observations were made for each section of the GMPs.

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Passing Cleanroom Inspections

Jeanne Moldenhauer
November 30th 2010

A review of warning letters from the last 10 years relating specifically to cleanrooms has indicated several concerns with the appropriateness of cleanroom design - primarily regarding air flow and laminarity.

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