Key Topics covered this year include
- MHRA – A regulatory vision for where 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.
Karen Capper, Director – Head of Microbiology, AstraZeneca - An updated review of reported recalls involving microbiological control with emphasis on FDA considerations around “Objectionable microorganisms”
Luis Jimenez – Professor, Bergen Community College (USA) – VIRTUAL - Update on the regulatory framework for recombinant technologies for Bacterial Endotoxin Testing (BET) in light of USP developments: A comprehensive overview on the tail of the USP new publication on recombinant reagents
Veronika Wills – Associate Director, Global Technical Services, Associates of Cape Cod Inc - Case study: Identification of contaminants using DNA sequencing
Elaine Kenny – Managing Director, Elda Biotechnology - Establishment of the monocyte activation test as a replacement of the rabbit pyrogen test – a roadmap
Maria Gajewi – Manager Endotoxin Services, Microcoat - Biofilm Remediation
Dan Klein – Senior Technical Services Manager, Steris - Pre-validation considerations for the implementation of an alternative, rapid sterility test method for an Adjuvanted Vaccine portfolio
Jayendra Shankar – Senior Manager, Global Microbiology QC/AS&T – Seqirus - 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
Tracy Moore – Founder & CEO, TM Pharma Group - Facts or Fake? Interpretation and significance of microbiological test results
Frank Mertens – Laboratory Consultant, Saercon - Evaluating the impact of Annex 1’s release (steriles & non steriles)
Andrew Hopkins, Senior Director – Lachman Consultants