Articles by Paula J. Shadle, PhD - BioPharm International

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Articles by Paula J. Shadle, PhD

Paula J. Shadle, PhD


Principal at Shadle Consulting

Articles
Managing the Global Supply Chain
May 1, 2008

Recent problems with food and pharmaceutical ingredients sourced from China highlight a major disadvantage of our complex international supply chains for food and drug ingredients. A global supply chain offers more opportunities for accidental contamination as well as intentional adulteration and counterfeiting. Sticking to minimal requirements may not be enough.

Writing Effective Development Reports
September 2, 2006

Development reports document process development and support the design of validation experiments, yet in many firms training is not provided nor are expectations established. This article describes how project managers can help scientists master the art of report-writing.

Overview of GMPs
November 15, 2004

What are current good manufacturing practices (cGMPs)? Where did they come from? What are the actual "practices" described in the Code of Federal Regulations, 21 CFR. If you are new to the pharmaceutical or biotechnology industries, you may enter your first "GMP Training" session without much context or perspective. A set of arcane rules is presented; you were never taught these in science classes.

BSE Offers Lessons in Risk Assessment
July 1, 2004

The approaches taken to containing the risk of BSE reveal patterns in the difficulties of performing and reacting appropriately to risk analysis.

Qualification of Raw Materials for Biopharmaceutical Use
February 1, 2004

This article focuses on the front end of qualifying a new raw material from a given supplier. Once qualified, this status must be maintained by periodic review and requalification.

GMP Issues: Moving QA onto the Manufacturing Floor
August 1, 2003

Many companies want to conduct quality assurance activities on the manufacturing floor. But implementation can be held up. Why?

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