• Inicio
  • Formações
  • Formação à Medida
  • News & Trends
  • Sobre nós
  • Contacto

GOOD PRACTICES FOR DATA MANAGEMENT AND INTEGRITY IN REGULATED GMP/GDP ENVIRONMENTS

The guidance has been written to apply to on-site inspections of those sites  performing manufacturing (GMP) and distribution (GDP) activities. The principles  within this guide are applicable for all stages throughout the product lifecycle. The guide should be considered as a non-exhaustive list of areas to be considered during  inspection.

 

Download here:

GOOD PRACTICES FOR DATA MANAGEMENT AND INTEGRITY IN REGULATED GMP/GDP ENVIRONMENTS

News & Trends

Procurar

Recentes

  • A Formiventos está novamente no ranking das Top 5% melhores PME de Portugal
  • Electronic Submission Template for Premarket Approval Applications (PMAs)
  • MDSAP Technical Review and Recognition Decision Procedure
  • Essential Principles and Content of Predetermined Change Control Plans. Final Document
  • Report on the International Active Pharmaceutical Ingredient Inspection Programme 2017 – 2024
  • GMP and GDP Question and Answer Guide Version 03 published by ECA
  • Guideline on good pharmacovigilance practices (GVP) Module III – Pharmacovigilance inspections (Rev 2)
  • Publication of COMBINE Project 2 Sponsors’ guide on safety reporting in combined studies

91 257 00 03 (Chamada para a rede móvel nacional)
info@formiventos.com

  • Follow
  • CLIENTES & TESTIMONIALS
  • ASSOCIAÇÕES OFICIAIS
  • CERTIFICAÇÕES E CREDITAÇÕES
  • ADVISORY BOARD
  • Política de Privacidade
  • Contacto