Articles
Filling Dangerous Cracks in the Pharmaceutical Supply Chain By Reginaldo Montague, CFPIM, CSCPDownload PDF Prescription for Product Safety APICS magazine (September/October 2016) With 80 percent…
Case Studies
Big new legislative requirements mean big changes at even the most efficiently run companies. But when the company uses project leadership to incorporate those changes…
Articles
With the Food Safety Modernization Act (FSMA) looming, food and beverage companies face some of the most sweeping safety regulations since Congress passed the Federal…
Articles
The clock is ticking toward 2018, when food companies of all sizes must comply with the federal mandates of the Food Safety Modernization Act (FSMA).…
Case Studies
Project Background Following the merger of two major pharmaceutical companies, the newly formed (merged) organization quickly recognized that the processes for creating, managing, and archiving…
Case Studies
Project Background A manufacturer of blood testing devices was scheduled to undergo an ISO audit of its Quality Management System (QMS). The successful completion of…
Articles
Three Steps a Manufacturer Used to Become “Recall Ready” Fueled by regulatory, legal, financial, and – most importantly – user concerns, product recalls are, frankly,…
Case Studies
Project Background A global manufacturer received an FDA mandate on one of its medical devices to repair, retire, or replace all units (more than 200,000)…
Case Studies
Project Background A major pharmaceutical company in-licensed a developmental pharmaceutical product nearing the end of Phase III clinical trials. At the time, the previous owner…
Case Studies
Project Background One of the world’s largest retailers wanted to achieve best-in-class quality for each item in their diverse portfolio of private label food and…