This year's meeting will address the following hot topics:

• MHRA – A regulatory vision for where the Pharma Micro industry is now and where it ‘could’ go. What should companies be thinking about?
• A global review and standardisation of the approach to the use of environmental isolates in AstraZeneca microbiology laboratories.
• An updated review of reported recalls involving microbiological control with emphasis on FDA considerations around “Objectionable microorganisms” 
• Update on the regulatory framework for recombinant technologies for Bacterial Endotoxin Testing (BET) in light of USP developments.
• Case study: Identification of contaminants using DNA sequencing
• Panel discussion session: AI (Artificial Intelligence) for GMP – where are we now? 
• Establishment of the monocyte activation test as a replacement of the rabbit pyrogen test – a roadmap
• Biofilm Remediation
• Pre-validation considerations for the implementation of an alternative, rapid sterility test method for an adjuvanted vaccine portfolio
• How the EM programme qualification is performed when only part of the facility is operational and what is then to be done to bring the next phases online
• Facts or Fake? Interpretation and significance of microbiological test results
• Evaluating the impact of Annex 1’s release (steriles & non steriles)
• Discussion sessions

Register here or contact the event organiser for more details using the green "Request Information" button below.