What Should Quality Executives be Thinking About When it Comes to FDA Risk Management?

Jack Garvey |

I love risk, and risk is something I live in every single day. I think it's really important to understand that when people talk about risk and FDA risk management, it's not about the elimination of all risk.... Read more

Risky Reliance – Be Careful with FDA’s New Compliant-Manufacturing Resumption Guidance

Jack Garvey |

Guidance Inartfully Mixes New and Old Expectations – Creates Confusion for Drug and Biologics Manufacturers As the COVID-19 pandemic continues, FDA continues its efforts to steward public health decision-making in an increasingly challenging regulatory climate.  FDA’s most recent... Read more

How to Keep Pharma/Biotech/Device Manufacturing Facilities Open Using Expedited Change Control

Jack Garvey |

For life science manufacturers concerned about third-party access to facilities, we have been recommending they add pre-entrance gowning to existing gowning procedures and extend the gowning envelope to the building exterior. This can be accomplished through an expedited... Read more