• 113 – Regulatory Inspections & Audits (S8E8)

  • May 4 2025
  • Duración: 12 m
  • Podcast

113 – Regulatory Inspections & Audits (S8E8)

Escúchala gratis

Ver detalles del espectáculo

  • Resumen

  • This episode outlines the inspection and audit processes used by regulatory agencies, such as the FDA, to ensure compliance with regulations in drug manufacturing and clinical trials. The conversation covers preparation for inspections, the conduct of audits, and follow-up steps. Documented examples highlight key aspects of the process.

    We highlight real-world examples of enforcement actions, including Form 483 observations, warning letters, and consent decrees, to illustrate the consequences of non-compliance. The discussion emphasizes the importance of maintaining meticulous records, adhering to Good Manufacturing Practices (GMP), and establishing robust quality systems. The episode also highlights sanction activities and the enforecment power of the FDA.
    Más Menos
Más Menos
adbl_web_global_use_to_activate_webcro805_stickypopup

Lo que los oyentes dicen sobre 113 – Regulatory Inspections & Audits (S8E8)

Calificaciones medias de los clientes

Reseñas - Selecciona las pestañas a continuación para cambiar el origen de las reseñas.

Reseñas de Audible.com

Opiniones de Amazon
No hay comentarios disponibles