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

Risk Management and Data Integrity: Focusing on the Critical

Jack Garvey |

The FDA has long taken a risk management approach to enforcement actions, as well as requiring drug and medical device manufacturers to do the same in their quality systems operations. Companies can turn the same risk management approach... Read more