• 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

  • ICH HARMONISED GUIDELINE GUIDELINE FOR GOOD CLINICAL PRACTICE E6(R3) Annex 2 .Final version
  • Team-NB Position Paper: MDR Certification Process (including Pre-application, Application and Post Application phases) – Consensus document
  • 2025 AI Observatory report
  • The EU new standard template covering recruitment and informed consent procedures.
  • EXTENSION OF THE MDR TRANSITIONAL PERIOD AND REMOVAL OF THE ‘SELL OFF’ PERIODS – Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607
  • MEDTECH EUROPE : An Improved Regulatory Framework: What Do Europe’s Diagnostics Need?
  • European Data Protection Board public consultation on the draft Guidelines on the processing of personal data for scientific research
  • Statistical Approaches to Establishing Bioequivalence

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