The 24th annual conference will bring speakers from the top multinationals GSK, AstraZeneca and Procter and Gamble as well as experts from the MRHA, Public Health England and from the US
The Pharmig annual conference in Nottingham, UK, on 16-17 November, will cover many of the hot topics facing microbiologist in the pharmaceutical sector.
EU GMPAnnex 1 revisions will be covered by MHRA inspector, Andrew Hopkins, (Expert GMDP), who will outline common inspection deficiencies for sterile manufacture, as well as key changes in Annex 1.
Julie Roberts, Quality Director, J. Roberts Associates, is back to cover the issue of data integrity within the microbiology laboratory and production facility. She will provide an overview of regulatory guidance on data integrity and the expectations of regulators.
Tony Cundell, Consulting Microbiologist, Microbiological Consulting LLC (USA), will provide an overview of the New England Compounding Centre fungal meningitis outbreak. He will cover microbiological monitoring and control in sterile compounding and how is it regulated in the US. Risk analysis, facility design, control and monitoring practices as well as sterility and bacterial endotoxins testing are all to be covered.
Paul Newby, SM Manager, GlaxoSmithKline will look at Rapid Microbiological Methods (RMM) and their application within GSK.
Dr. Kevin Wright, Principal Scientist Microbiology Capability Organisation, Procter & Gamble will discuss the transfer of microbiological methods between laboratories. In particular, he will look at GMP Chapter 6: Quality Control, including method transfer protocol and what to watch out for!
Practical insight from Public Health England (PHE) on pseudomonas and water will be provided by Bharat Patel, Consultant Medical Microbiologist, PHE. He will look at the pseudomonas incident in Northern Ireland which affected 25 babies in neonatal intensive care and how a wide ranging independent review has increased our understanding of the link between pseudomonas and water.
Tony Cundell returns to talk about case studies in bioburden control in the manufacture of non-sterile drug products. Critical quality attributes of non-sterile products, microbial count, absence of specified microorganisms, absence of objectionable microorganisms and risk mitigation steps will be included.
Laura Guardi, Senior QA Auditor, AstraZeneca, will look at environmental monitoring risk assessment and what test methods should be selected and their pitfalls. She will also discuss recent examples of warning letters and how to prepare the validation package for inspection.
Anna Lovatt, Microbiology Manager Oral Health, GlaxoSmithKline, will give a summary of different microbial identification systems available and key considerations in choosing a system.
Edel Fitzmaurice, Managing Director, Fitzmaurice Scientific, will consider the use of HACCP for reducing microbiological contamination and as a risk analysis tool.
The proceedings will wind up with Pete Gough, Executive Director, NSF Health Sciences Pharma Biotech Consulting, looking at the potential impact of Brexit for companies making pharmaceutical and biopharmaceutical in the UK.