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

CBD Manufacturers Must Develop GMPs Even Absent FDA Instructions

Jack Garvey |

Cannabidiol (CBD) is the latest “it” product. Companies across the US and internationally are eager to manufacture CBD or incorporate CBD into a variety of other products. Despite a recent Draft Guidance issued by FDA on July 22, 2020... Read more

Risk Management and Data Integrity: Focusing on the Critical

Jack Garvey |

The FDA has long taken a risk-based approach to manufacturer GMP compliance expectations and enforcement actions, as well as requiring pharmaceutical and medical device manufacturers to do the same in their quality system operations. Similarly, companies can also... Read more