Articles by Susan J. Schniepp - Pharmaceutical Technology

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Articles by Susan J. Schniepp

Defining Quality Metrics to Ease Drug Shortages

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

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

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.

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FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
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Expedited reviews of drug submissions
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Reducing drug shortages
70%
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4%
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17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerRelationship-building at Top of Mind for Clients
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerRisk Reduction Top Driver for Biopharmaceutical Raw Material Development
Jill Wechsler Regulatory Watch Jill Wechsler Changes and Challenges for Generic Drugs
Faiz Kermaini Industry Insider Faiz KermainiNo Signs of a Slowdown in Mergers
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