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

EDQM TRAINING MODULE 7 Control of impurities: CEP approach

This module addresses in detail how to  hashtag#controlimpurities  in  hashtag#activesubstances  in the context of a  hashtag#CEPapplication .
The presentation outlines how to build and justify an appropriate control strategy, not only for  hashtag#organic  and  hashtag#mutagenicimpurities  but also for  hashtag#elementalimpurities  and organic solvents.
Concepts are illustrated with concrete examples and applicable  hashtag#regulatoryrequirements  are described.

The recording below includes a Q&A session.

https://lnkd.in/dzeKrQEV

Below the link for download the presentation

https://lnkd.in/dB8eZQ63

News & Trends

Procurar

Recentes

  • AI Act Complaints tool
  • EU MDR Update: New Harmonised Standards for Medical Devices
  • Clinical evidence for orphan in vitro diagnostic medical devices
  • Questions and answers for marketing authorisation holders/applicants referral on nitrosamine impurities in human medicinal products
  • TEAM NB Code of Conduct for Notified Bodies vs 5.3
  • GIRP POSITION PAPER: Revision of the EU Guidelines on Good Distribution Practice for Medicinal Products for Human Use
  • New guidance document MDCG 2026-6 on Guidance on clinical evidence for orphan IVDs
  • AI in pharmacovigilance – EMA update

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