Andrew Harrison

Andrew Harrison is chief regulatory affairs officer and general counsel with Regulatory Compliance Associates.

Articles

Requirements for Product Technology Transfer

April 2nd 2016

Susan Schniepp, distinguished fellow, and Andrew Harrison, chief regulatory affairs officer and general counsel, both of Regulatory Compliance Associates, discuss requirements for successful product technology transfer.

Creating Robust CAPA Systems

Andrew Harrison;Susan J. Schniepp

February 2nd 2016

Susan Schniepp, distinguished fellow, and Andrew Harrison, chief regulatory affairs officer and general counsel, both of Regulatory Compliance Associates, discuss how to create a robust CAPA system and how to identify root cause.

Crafting Standard Operating Procedures

Andrew Harrison;Susan J. Schniepp

December 2nd 2015

Susan Schniepp, distinguished fellow, and Andrew Harrison, chief regulatory affairs officer and general counsel, both of Regulatory Compliance Associates, discuss how to write standard operating procedures that hold up to audits.

Investigating Biologics

Andrew Harrison;Susan J. Schniepp

October 2nd 2015

Susan Schniepp, distinguished fellow, and Andrew Harrison, chief regulatory affairs officer and general counsel, both of Regulatory Compliance Associates, discuss performing investigations of biological products.

The Metrics of Quality Culture

Andrew Harrison;Susan J. Schniepp

September 2nd 2015

FDA’s proposed guidance for quality metrics raises questions about quantifying the tangibles and intangibles of quality culture.

Defining Crucial CAPA Components

Andrew Harrison;Susan J. Schniepp

August 2nd 2015

Susan Schniepp, distinguished fellow, and Andrew Harrison, chief regulatory affairs officer and general council, both of Regulatory Compliance Associates, discuss the requirements for a successful corrective action and preventive action (CAPA) system.