Jeanne Moldenhauer
Mundelein, Illinoisquality assurance/regulatory affairs
sterilization and validation processes
healthcare industry
Device, NDA, sNDA, ANDA, and DMF submissions to FDA
CMC development for drugs
sterile process validation documentation
rehabilitation of companies with negative FDA findings
assessing and validating laboratory and production facilities
quality improvement
cost savings
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aseptic processing
sterilization
rapid methods
quality management
quality engineering
rapid microbiology
sterility assurance
risk assessment
compliance
regulatory submissions
Microbiology
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