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

6 Reasons to Work with an Interim Expert/Executive Placement Firm — Amazing How Executives Don’t Recognize the Risks in No. 4

Jack Garvey |

The Opportunity Cost of Swapping Staff from One Project to Another: The need to constantly swap internal resources to keep projects on-track can severely limit FDA-regulated companies from maintaining quality and staying in compliance. Instead of improving operations,... Read more