Articles by Siegfried Schmitt - Pharmaceutical Technology

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Articles by Siegfried Schmitt

Data Integrity

Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses how to ensure data integrity.
Jul 2, 2014

Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses how to ensure data integrity.

Key Considerations for Quality-Technical Agreements

A drug sponsors responsibility does not end when a task is outsourced.
May 30, 2014

A drug sponsor?s responsibility does not end when a task is outsourced.

Quality-Technical Agreements

Siegfried Schmitt, principal consultant at PAREXEL, discusses the importance of quality-technical agreements.
May 2, 2014

Siegfried Schmitt, principal consultant at PAREXEL, discusses the importance of quality-technical agreements.

The Human Factor

Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses how human error can be mitigated in pharmaceutical manufacturing.
Feb 2, 2014

Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses how human error can be mitigated in pharmaceutical manufacturing.

The State of Drug Manufacturing in India

Siegfried Schmitt, principal consultant at PAREXEL, discusses the state of drug manufacturing in India.
Jan 31, 2014

Some recent high-profile cases of quality issues at Indian manufacturers have given reason to examine manufacturers more closely.

Drug Manufacturing Focus: Why India?

Siegfried Schmitt, principal consultant at PAREXEL, discusses the state of drug manufacturing in India.
Dec 2, 2013

Siegfried Schmitt, principal consultant at PAREXEL, discusses the state of drug manufacturing in India.

The Role of Analytical Science in Implementing Quality by Design

The authors present topics discussed and conclusions that resulted from the PDA QbD workshop.
Mar 2, 2013

The authors present topics discussed and conclusions that resulted from the PDA QbD workshop.

The Freeze Drying Challenge

Apr 1, 2012

There are no two completely identical freeze dryer units in operation anywhere.

A Perspective on Computer Validation

This article provides a historical review of computer validation in the pharmaceutical industry within the last three decades, evolving from the early years' initial concept and approach to today's current practices. Also included is how the regulations and industry have progressed in addressing the topic of computer validation.
Jul 2, 2007

This article provides a historical review of computer validation in the pharmaceutical industry within the last three decades, evolving from the early years' initial concept and approach to today's current practices. Also included is how the regulations and industry have progressed in addressing the topic of computer validation.

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