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DESCRIPTION:Sponsored by: Bioscience International\, Associates of Cape Co
 d and MicrobiologicsChaired by: Jim Polarine\, Senior Technical Service M
 anager\, Head of Microbiology &amp\; Sterile Technology\, STERIS Corporat
 ion\n\nSMi’s 5th Annual Pharmaceutical Microbiology East Coast Conference
  is taking place in Boston on April 27-28\, 2022\, with interactive works
 hops on April 26\, 2022.\n\nMicrobiology remains an essential tool in red
 ucing microbial growth in the manufacture of pharmaceuticals\, to detect 
 and eliminate microorganisms that would pose a risk to patients and jeopa
 rdise product batches.\n\nEnsuring the sterility of the finished product 
 continues to be one of the most critical aspects of drug development\, ho
 wever an array of factors are also sustaining new growth and transformati
 on in this field. The regulatory landscape is changing\, firstly with the
  preparation of Annex 1\, in addition to increasing requirements pertaini
 ng to data integrity. Light is being shed on recent product recalls for m
 ould contamination\, and infection outbreaks serve as a reminder to pay m
 ore attention to these overlooked organisms\, as well as considerations t
 owards container closure integrity testing which is being increasingly de
 ployed to block microbe movement.\n\nOn top of this\, the developing inte
 gration of automation and robotics into the manufacturing pipeline\, as w
 ell as the increased need for more rapid microbiology methods brought abo
 ut in part by the surge in ATMPs\, are all highlighting the necessity of 
 the field in Pharma.\n\nThis industry is ever expanding\, join leading ex
 perts in 2022 to discuss and analyse the latest advances and challenges s
 urrounding Pharmaceutical Microbiology. Network with industry professiona
 ls\, discuss revisions in regulatory and guidance documents\, and gain a 
 deeper insight into this corner of the field.\n\nKey Highlights for 2022:
 \n\n• Review implementation guidance and validation for efficient disinfe
 ctant efficacy programs• Uncover principles in best-practice and the bene
 fits of a robust contamination control strategy• Address fungal mould con
 tamination and risk-based tools to tackle spore spreading• Delve into the
  sterility assurance assessment and holistic closure integrity testing• E
 xplore the impact of the ongoing pandemic and the changing face of the ph
 arma industry• Understand new unique case studies\, from contamination co
 ntrol as it relates to microbiome products\, to risk-based assessments of
  traditional microbiological tests• 2 Interactive Pre-Conference Workshop
 s on April 26\, 2022\n\nInteractive Workshops on 29 April 2022:Workshop A
 : Risk Assessment and Cleaning ValidationWorkshop Leader: Fred Ohsiek\, S
 ME\, Cleaning Validation\, North America\n\nWorkshop B: USP Microbiology 
 2022 – Keeping Up with StandardsWorkshop Leader: Donald Singer\, Chair\, 
 General Chapters - Microbiology Expert Committee\, US Pharmacopeia and Ec
 olab Life Sciences\n\nWHO SHOULD ATTEND?Senior Microbiologist\, Lead Scie
 ntist\, Laboratory Manager\, QA Specialist\, Drug Substance External Manu
 facturer\, QC Scientists\, Heads of Quality\, Business Development Manage
 r\, Pharmaceutical Microbiology Consultant\, Higher Pharmacopoeia Scienti
 st\, Analytical Standards Specialist\n
DTEND:20220428T173000
DTSTAMP:20260525T140818Z
DTSTART:20220427T080000
LOCATION:Sheraton Boston Hotel\, 39 Dalton St\, Boston\, MA\, 02199\,
SEQUENCE:0
SUMMARY:Sponsored by: Bioscience International\, Associates of Cape Cod an
 d MicrobiologicsChaired by: Jim Polarine\, Senior Technical Service Manag
 er\, Head o...
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