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Risk Analysis of Sterility Testing in an Isolator Environment

Pharmaceutical Microbiology Meeting - LondonSMi Group reports that Hans Noordergraaf, Microbiologist, Abbot Biologicals B.V. will be presenting at the Pharmaceutical Microbiology 2016 conference on a session entitled: 'Risk analysis and mitigation of the analysis process of sterility testing in an isolator environment.' Hans Noordergraaf is a microbiological expert on a global level supporting different sites / products with regard to troubleshooting in production processes, regulatory filing and rapid techniques.

In his presentation Hans Noordergraaf will focus on “false positive” sterility tests are a major concern for business continuity; a non-zero percentage sterility test failure rate as a regulatory auditor topic which can be avoided; how to use FMEA as a tool to reduce risk of “false positives” implementation of risk mitigation and on it’s influence on sterility test failure rate. The audience will benefit from the discussion on risk assessment as a key tool in prevention of failures in either analysis or processes.

The Pharmaceutical Microbiology 2016 event will explore developments in mechanisms to detect pathogens, case studies on contaminations, endotoxin detection and LER, case studies in pharmaceutical microbiology, regulatory changes and VBNC's.

Plus two interactive pre-conference workshops :

A) Spectrometric and Optical Technologies for Microbial Contamination Control (led by Battelle)

B) Endotoxin Testing: Hot Topics and New Methods in the European Pharmacopoeia (led by Hyglos GmbH)

Key speakers and experts include:

  • Oliver Chancel, Sterility and Aseptic Process Assurance Expert, Merial Sas
  • Francesco Boschi, Microbiological Services Manager, GSK Manufacturing S.p.A
  • Salomé Gião, Research Scientist, Dyson Technology Ltd
  • Thierry Bonnevay, Microbiology Platform Head QC Development, Sanofi Pasteur
  • Adrianne Klijn, Group Leader Microbiological and Molecular Analytics, Nestle Research Center
  • Sabina Lancaster, Senior Manager, Sterility Assurance, Global, QA, GSK
  • James Drinkwater, Chairman, PHSS
  • Tim Eaton, Sterile Manufacturing Specialist, AstraZeneca

For full speaker outline please visit: www.pharma-microbiology.com/rapidmicro

To register please contact Matthew Apps: +44 (0) 207 827 1093, mapps@smi-online.co.uk Rapidmicrobiology visitors can get 150 GBP off on-line bookings by quoting code SMIDZ4C.

Confirmed Sponsors for 2016 – Hyglos, Lonza, Merck Millipore, IDEXX Laboratories, Mettler Toledo, for sponsorship enquiries please contact Alia Malick: +44(0)2078276748 amalick@smi-online.co.uk

     
Tags: Isolator

Date Published: November 9, 2015

Source article link: SMi Group
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