Trump, Regulatory Reform & FDA Compliance: The Impact of the US Election on FDA Regulatory Enforcement

Jack Garvey |

The election of Donald Trump as President-Elect of the United States was, and continues to be, a watershed moment in the 200+ year American experiment.   The public, the business community, and government are all currently adjusting to a... Read more

Quality Agreements – Cornerstone of Product Supply Relationships

Teresa Gorecki |

I worked for a Chief Quality Officer a number of years ago who always had this response when our company was contemplating movement of a large volume of internal production to third parties: “You can delegate your responsibilities... Read more

FDA “Live Review” Inspection of Company Documentation: Are You Ready?

Teresa Gorecki |

The following was included in our July email newsletter. There are many training sessions conducted each year by GMP Training Managers and company quality and compliance staff on “How to Manage an FDA Inspection”. Regularly, FDA inspection management... Read more