Articles by Susan J. Schniepp - Pharmaceutical Technology

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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 2, 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 2, 2013

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

The Human Error Behind Human Error

A thorough investigation of all possible causes of deviations should be performed.
Feb 2, 2013

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

Advice for Enhancing the Client–Sponsor Relationship

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

How FDA, USP, and ICH have redirected industry practice.
Jul 2, 2012

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

Know the Regulations

The contract provider needs to know as much as the NDA holder.
Apr 2, 2012

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

Managing the Quality Relationship for a Contractual Agreement

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.
Feb 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.

Auditing by the Numbers

Contract organizations must have highly organized teams and plans to accommodate today's audits.
Dec 2, 2011

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

Where in the World is the US Pharmacopeia?

After a series of structural changes, the author wonders whether USP is undergoing an identity crisis. USP CEO Roger L. Williams responds.
Sep 2, 2011

After a series of structural changes, the author wonders whether USP is undergoing an identity crisis. USP CEO Roger L. Williams responds.

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