Paula J. Shadle, PhD



Principal at Shadle Consulting


Managing the Global Supply Chain

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

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

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.

GMP Issues: Breaking Ground

by Paula Shadle, Shadle Consulting When building a biotech manufacturing facility and a QC lab, which scenario do you choose ? build manufacturing first, build the QC lab first, or build both facilities simultaneously?