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Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.
March 02, 2015
A new technical report guides bio/pharma companies in establishing a risk-based approach for prevention and management of drug shortages.
May 30, 2014
Industry players and FDA evaluation possible quality metrics to improve manufacturing efficiencies and avoid drug shortages.
May 02, 2014
Industry players offer suggestions for quality metrics as FDA continues to try and solve the problem of drug shortages.
September 02, 2013
Establishing a well-defined training program is a crucial activity for any biopharmaceutical organization.
June 02, 2013
Companies can use metrics as a tool to help drive positive change and quality process improvements.
February 02, 2013
A thorough investigation of all possible causes of deviations should be performed.