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Articles

Common Regulatory Submission Pitfalls and Ways to Avoid Them

By Susan Carino, Principal Consultant, and Ruba Hadidi, Project Management Consultant Integrated Project Management Company, Inc. (IPM) No matter your company size or phase of…

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Case Studies

Regulatory Expertise Eases the Way for Company’s First IND Submission

A young biopharmaceutical company developing a pipe-line of preclinical cancer immunotherapy treatments was preparing to file its first investigational new drug (IND) application with the…

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Articles

Using CAPA to Comply with FSMA Can Improve Safety + Profits

The implementation of the Food Safety Modernization Act of 2011 (FSMA) has forced food and beverage manufacturers to face some of the most sweeping safety…

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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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News

Preparing for the Food Safety Modernization Act (FSMA)

Compliance requirements for the Food Safety Modernization Act (FSMA) are a concern for food and beverage companies of all sizes. Even after compliance, companies must…

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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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