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Effectively Manage Audits across the Enterprise with Your EQMS

Pharmaceutical companies must audit against many regulations and internal standards, with the primary audit groups focused on GMP, GCP, and GLP auditing.  Though they share the auditing title and are...

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A Closer Look at FDA’s Final Rule for 21 CFR Part 4 – Current Good...

On January 22, 2013 the FDA published the Final Rule for “Current Good Manufacturing Practices for Combination Products” in the Federal Register.  This rule is designated 21 CFR Part 4, and becomes...

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The Value of an Enterprise Quality Management System in Pre-Clinical and...

After working with hundreds of pharmaceutical companies for years, I have noticed that while there is a single company name on the building, there are dividing walls within.  These walls tend to be...

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[INFOGRAPHIC] Maximizing Supply Chain Efficiency and Quality on a Global Scale

Consumer product companies typically manage a vast and complex production process across different product lines, divisions, plants and regions. The company’s network consists of suppliers, contract...

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New Trend in Manufacturing: Vertical Integration Through Strategic Supplier...

The first question that comes to mind is “how can you ensure quality, reliability and safety amid your expansion and vertical integration of your supply chain through greater industrial partnership,...

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