Sponsored by: Bioscience International, Associates of Cape Cod and Microbiologics
Chaired by: Jim Polarine, Senior Technical Service Manager, Head of Microbiology & Sterile Technology, STERIS Corporation
SMi’s 5th Annual Pharmaceutical Microbiology East Coast Conference is taking place in Boston on April 27-28, 2022, with interactive workshops on April 26, />
Microbiology remains an essential tool in reducing microbial growth in the manufacture of pharmaceuticals, to detect and eliminate microorganisms that would pose a risk to patients and jeopardise product />
Ensuring the sterility of the finished product continues to be one of the most critical aspects of drug development, however an array of factors are also sustaining new growth and transformation in this field. The regulatory landscape is changing, firstly with the preparation of Annex 1, in addition to increasing requirements pertaining to data integrity. Light is being shed on recent product recalls for mould contamination, and infection outbreaks serve as a reminder to pay more attention to these overlooked organisms, as well as considerations towards container closure integrity testing which is being increasingly deployed to block microbe />
On top of this, the developing integration of automation and robotics into the manufacturing pipeline, as well as the increased need for more rapid microbiology methods brought about in part by the surge in ATMPs, are all highlighting the necessity of the field in />
This industry is ever expanding, join leading experts in 2022 to discuss and analyse the latest advances and challenges surrounding Pharmaceutical Microbiology. Network with industry professionals, discuss revisions in regulatory and guidance documents, and gain a deeper insight into this corner of the />
Event Hashtag: #SMiPharmaMicroEC
Key Highlights for 2022:
Interactive Workshops:
Workshop A: Risk Assessment and Cleaning Validation
Workshop Leader: Fred Ohsiek, SME, Cleaning Validation, North America
Workshop B: USP Microbiology 2022 – Keeping Up with Standards
Workshop Leader: Donald Singer, Chair, General Chapters - Microbiology Expert Committee, US Pharmacopeia and Ecolab Life Sciences
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, Analytical Standards Specialist
27 Apr 2022 @ 08:30 am
28 Apr 2022 @ 05:30 pm
Duration: 1 days, 9 hours
Sheraton Boston Hotel
39 Dalton St
02199 Boston
United States
English en