November 12th, 2018
In the manufacture of any medical device or pharmaceutical product, validation and verification are two pivotal terms. We’ll break down the differences and use the production of a transdermal patch to provide examples of how they apply to the manufacturing process.
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December 21st, 2015
Validation of your converting processes is critical, and GAMP is your guiding light. Developing your validation attributes requires focus on three critical areas, with a particular emphasis on the quality attributes that define your product.
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November 30th, 2015
Regardless of your feelings toward federal mandates, they often provoke changes within an industry. The new FDA mandate regarding UDIs (Unique Device Identifiers) will significantly change how medical device manufacturers approach product development, data integration, and contract manufacture.
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