MEDICAL DEVICE BLOG

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How Key Pharma and Device Executives Are Developing the Next Generation of Quality Professionals and Leaders

A team comprising over a dozen chief quality officers (CQOs) representing the medical device, pharmaceutical, animal health, and consumer healthcare industries has pooled its collective passion and wisdom – with input from FDA and other drug and device regulatory agencies – to establish and implement an innovative education curriculum that will help develop the next generation of scientists entering the industry.

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FDAzilla’s Top 20 Posts of All Time

Over the years, the FDAzilla blog has published over 650 articles. We hope this compilation will serve as a resource for you and your company.  It should also help orient you to the scope of the FDAzilla blog as you continue to follow our efforts to provide accessible FDA data and insights.

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Software Validation

Identification of Software Validation Shortcomings

GMP/GCP compliance failures in the drug product segment are no longer identified as the ‘software not being validated for its intended use’, but rather the deficiencies are now linked to the predicate GMP requirements based on FDA’s stated focus in 2010.

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FDA WARNING LETTERS

FDA FORM 483s