QUOTED. Jan. 22, 2019. Susan Neadle.
Combination products add complexities to many parts of the regulatory process, and that includes US FDA facitilty inspections. J&J's Susan Neadle highlights here the importance of speaking the language of both drug and device regulations when an investigator shows up at your combo product facility.
- Find out more: Compliance Corner: J&J Quality Expert Urges Makers Of Combo Products To Be 'Bilingual' In Device- And Drug-Speak