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Ten Most Common Reasons for FDA 483 Inspectional Observations in Pharmaceutical Environments
Ten Most Common Reasons for FDA 483 Inspectional Observations in Pharmaceutical Environments

The U.S. Food and Drug Administration has released data on the most common observations it makes during ins...

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ISO 13485 - Change? Do I Have To??
ISO 13485 - Change? Do I Have To??

Review the conundrum companies are experiencing if they want to maintain both ISO 9001 and ISO 13485 certif...