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

FDA Announces New Office of Dietary Supplement Programs (ODSP)

Jack Garvey |

Opportunities and Risks for Dietary Supplement Companies for 2016 and Beyond 2015 is certainly ending with a bang.    As many of us industry insiders have known for some time, FDA has been planning changes to their regulation and... Read more