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Articles

Prescription for Product Safety

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…

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Case Studies

Beyond Compliance: Device Firm Reaps Benefits from Project Leadership

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…

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Articles

FSMA Compliance Tips from the Life Sciences Industry

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…

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Articles

Don’t Get Flattened by the FSMA Steamroller

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).…

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Case Studies

Harmonizing a Global Regulatory Submission Process Post-Merger

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…

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Case Studies

Process Mapping Workshops Save Imperiled ISO Certification

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…

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Articles

Overcome a Product Recall Nightmare

Three Steps a Manufacturer Used to Become “Recall Ready” Fueled by regulatory, legal, financial, and – most importantly – user concerns, product recalls are, frankly,…

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Articles

Compliance Issues? First, Don’t Panic

Abstract: Meeting compliance issues is like preparing for a hurricane: both situations require making sure that everything is nailed down well before the storm hits.…

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Case Studies

Successful Medical Device Design Transfer Lifts One of the Largest FDA Mandates in History

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)…

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Case Studies

Coordination Secures On-Time Biopharmaceutical NDA Submission and Launch

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…

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