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Microbial Safety of Raw Materials and Excipients

9 November 2016

Objectives

This conference is designed to provide you information of the pharmacopoeial requirements, possible issues with special substances, microbiological challenges and necessary tests during life cycle.

During this Conference we discuss:

  • International regulatory requirements
  • What should be tested
  • Skip lot testing
  • Specific pitfalls e.g. toxicity issues, inhomogenous distribution of contaminants
  • Storing and retesting

Highlights

  • Regulatory Framework
  • Virussafety Strategies
  • Strategies for Reduced Testing of Excipients
  • Riskassessment
  • Water Testing and Biofilms

Speakers

  • Dr Anja Fritsch, Confarma France
  • Dr Ralf Klein, ViruSure, Austria
  • Dr Mauel Leitner, Ages, Austria
  • Dr Laurent Leblanc, BioMerieux, France
  • Dr Ingrid Mecklenbräuker, Novartis Pharma Stein, Switzerland
  • Dr Jelena Novakovic, Galenika, Serbia
  • Christine Weiß, Labor L+S AG, Germany