Articles by Susan J. Schniepp - BioPharm International

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Articles by Susan J. Schniepp

The Elements of Training

Establishing a well-defined training program is a crucial activity for any biopharmaceutical organization.
Sep 1, 2013

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

The Meaning of Metrics

Companies can use metrics as a tool to help drive positive change.
Jun 1, 2013

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

Know the Regulations

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

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.
Mar 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

Contract organizations must have highly organized teams and plans to accommodate today's audits.
Jan 1, 2012

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

Following Our Own Instructions

Why SOPs are rarely followed, often cited, and in great need of follow-through.
Sep 1, 2011

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

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