Articles by Susan J. Schniepp - Pharmaceutical Technology

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Articles by Susan J. Schniepp

Susan J. Schniepp


Susan J. Schniepp is the president of Schniepp and Associates and a member of Pharmaceutical Technology's Editorial Advisory Board.

Articles
Defining Quality Metrics to Ease Drug Shortages
May 30, 2014

Industry players and FDA evaluation possible quality metrics to improve manufacturing efficiencies and avoid drug shortages.

Linking Drug Shortages and Quality Metrics
May 2, 2014

Industry players offer suggestions for quality metrics as FDA continues to try and solve the problem of drug shortages.

The Elements of Training
September 2, 2013

Establishing a well-defined training program is a crucial activity for any biopharmaceutical organization.

The Meaning of Metrics
June 2, 2013

Companies can use metrics as a tool to help drive positive change and quality process improvements.

The Human Error Behind Human Error
February 2, 2013

A thorough investigation of all possible causes of deviations should be performed.

Advice for Enhancing the Client–Sponsor Relationship
November 2, 2012

Key talks from the recent PDA/FDA regulatory conference highlight room for improvement.

35th Anniversary Special: The Transformation of Regulation and Global Standards
July 2, 2012

How FDA, USP, and ICH have redirected industry practice.

Know the Regulations
April 2, 2012

The contract provider needs to know as much as the NDA holder.

Managing the Quality Relationship for a Contractual Agreement
February 1, 2012

The author describes an equation that can be used to define the Quality relationship between a contract manufacturing organization and a client, including how to factor in both party's needs and regulatory commitments.

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