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Compliance Corner: J&J Quality Expert Urges Makers Of Combo Products To Be 'Bilingual' In Device- And Drug-Speak

 
• By Shawn M. Schmitt

Speaking the language of both devices and drugs is an important step sometimes missed by makers of combination products. Being "bilingual" is especially important during a facility inspection by US FDA, Johnson & Johnson's Susan Neadle says.

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When US FDA investigators showed up to inspect a Johnson & Johnson facility in Europe that makes combination drug-device products, Susan Neadle realized that the J&J employees she had on hand to answer the auditors' questions weren't speaking the correct language.

But the problem wasn't a failure to speak English, Spanish, German or any other type of conventional language. Rather, Neadle's employees at that particular plant weren't speaking the language of...

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