SMi’s 3rd Annual Pharmaceutical Microbiology East Coast Conference
April 29 - 30, 2020 - Boston MA USSMi Group
ssapal@smi-online.co.uk
Phone:02078276000
SPONSORED BY: Associates of Cape Cod, bioMérieux, Bioscience International, C.T.L. MAT, LONZA CHAIRED BY: Lynne Ensor,VP Technical, Parexel The pharmaceutical microbiology industry has seen many changes during the progression into the 21st century. With advances in rapid microbiological methods, revisions being made to regulations in the industry, enhanced knowledge of the human microbiome, and novel testing methods, this industry is ever expanding. Join industry experts to discuss and analyze the latest advances and challenges within the industry. Network with industry professionals, discuss the revision of Annex 1, explore data integrity considerations for conventional and rapid microbiology methods, analyze arising issues with environmental monitoring and gain insight into an industry perspective on automated endotoxin testing and process automation. HIGHLIGHTS FOR 2020: • Discuss ongoing complication of personnel derived contamination from the FDA • Gain valuable insight towards microbiological quality considerations in non-sterile manufacturing and control of BCC from Parexel • Learn from the perspective of the US Pharmacopoeia on container closure integrity evaluation • Examine an end-to-end contamination risk assessment for autologous cell therapy from Juno Therapeutics • Explore a back to back Genentech session covering technical considerations for microbial QC of raw materials used in biotechnology and the past, current and future state of Mycoplasma testing Post-Conference Workshop – May 1, 2020 The Use of Recombinant Chromogenic Assays as Alternate Methods for the Bacterial Endotoxins Test (BET) Workshop Leader: Veronika Wills, Manager, Technical Services, Associates of Cape Cod WHO SHOULD ATTEND: Senior Microbiologist, Lead Scientist, Laboratory Manager, QA Specialist, Drug Substance External Manufacturer, QC Scientists, Heads of Quality, Business Development Manager, Pharmaceutical Microbiology Consultant, Higher Pharmacopoeia Scientist.