Articles by Susan J. Schniepp - BioPharm International



Articles by Susan J. Schniepp

Susan J. Schniepp

Linking Drug Shortages and Quality Metrics
May 1, 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 1, 2013

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

The Meaning of Metrics
June 1, 2013

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

Know the Regulations
June 1, 2012

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

Managing the Quality Relationship for a Contractual Agreement: A CMO Perspective
March 2, 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.

Auditing by the Numbers
January 1, 2012

Contract organizations must have highly organized teams and plans to accommodate today's audits.

Following Our Own Instructions
September 1, 2011

Why SOPs are rarely followed, often cited, and in great need of follow-through.



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