Communication de Scott Gottlieb FDA Commissioner

Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s efforts to improve drug quality through vigilant oversight of data integrity and good manufacturing practice
Ensuring the safety of our nation’s drug supply is a cornerstone of our consumer protection mission. Overseeing the quality and safety of pharmaceutical manufacturing is key to these efforts. With the emergence of new markets, supply chains are more complex. Drug production and testing operations have also become more computerized. These changes represent new opportunities and challenges. Having clear guidelines for companies on how to prevent product quality issues is an important step to protecting patient safety and preventing drug shortages of critical medicines. To meet these challenges, our policies and guidance must also evolve to ensure that quality standards are maintained, and to assist companies in building a culture of quality. To that end, one area we’ve focused new attention on in recent years is…

La "data integrity" dans les laboratoires de contrôle non pharmaceutiques

Un exemple médiatisé des pratiques de "retest into compliance" dans l'industrie agro-alimentaire.

Plus d'information ici.

L'utilisation des données de sérialisation

Michele D'Alessandro, Vice President and CIO, Manufacturing IT at Merck & Co., Inc. partage des conseils sur la façon dont les données de sérialisation peuvent être utilisées, quels défis doivent être surmontés et les applications pratiques : Big data, apprentissage automatique et intelligence artificielle sont au programme.

Plus d'information ici et .