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SMi's 4th Pharmaceutical Microbiology West Coast

Novel approaches and best practices for tackling current industry contamination control challenges

Conference: 17 – 18 June 2021
Workshops:  16 June 2021
Location: Hyatt Regency Mission Bay Hotel, San Diego, CA, USA


SPONSORED BY: Associates of Cape Cod, bioMérieux, Bioscience International, Microcoat,  Millipore Sigma & Mettler Toledo

Co-chairs Jim Polarine,
Senior Technical Service Manager, STERIS Corporation & Geeta Singh, Plant and Network Technical Specialist III, Genentech

Following on the success of the past West Coast events, SMi proudly presents the 4th Annual Pharmaceutical Microbiology West Coast Conference, in San Diego, USA, on June 17th and 18th 2021 bringing microbiology experts to focus on innovations in rapid methods and contamination control strategies. Microbes such as bacteria, fungi, parasites and viruses that can contaminate current and novel pharmaceutical products or therapies may stem from various sources such as raw materials and human operators, are taken into consideration.

This concern is critical in advanced products/therapeutics facilities where often distinct areas within manufacturing are slowly merging, providing potential new sites for contamination events. The conference showcases sessions that cover alternative endotoxin testing and rapid mycoplasma testing as well as implementation of in-line biodurden monitoring to control water systems, to name a few. Due to the complexities brought about by more advanced therapeutic products, both drugs and patients are time dependent and rapid methods are ever more desired.

A significant portion of the conference will focus on contamination control strategies and facilities support/novel technologies such as a look at a sustainable global contamination control program, cleanroom pass thru best practices and a case study executing rapid transition from clinical to commercial manufacturing and more. Also see a regulatory session discussing objectionable organisms in non-sterile drug products and an all-women panel discussion: ‘culturing’ successful women microbiologists.

Event Hashtag: #SMiPharmaMicroWC

KEY HIGHLIGHTS FOR 2021 INCLUDE:

  • Discuss the guidance, regulations and case studies for objectionable organisms in non-sterile drug products from ValSource, Inc.
  • Gain insight into changing paradigms – moving to in-process testing from Johnson & Johnson
  • Examine alternative endotoxin test methods for products exhibiting LER from Amgen
  • Explore how to effectively scale up from clinical to commercial in three moves from Bristol-Myers Squibb
  • Join us for our first All-Women Panel Discussion on ‘Culturing’ successful women microbiologists


Plus a half day interactive workshop on Wednesday, June 16th 2021:
Afternoon Workshop: Data Integrity in Environmental Monitoring: Causes and Solutions
Led by: Ziva Abraham, CEO, Microrite and Morgan Polen, SME, Cleanroom Contamination Control Expert, Microrite

WHO SHOULD ATTEND
Senior Microbiologist, Lead Scientist, Laboratory Manager, QA Specialist Drug Substance External Manufacturer, Business Development Manager – Testing, Pharmaceutical Microbiology Consultant, Higher Pharmacopoeia Scientist, Analytical Standards Specialist

When

17 Jun 2021 @ 08:30 am

18 Jun 2021 @ 08:31 am

Duration: 1 days


Where

HYATT REGENCY MISSION BAY

1441 Quivira Road

92109 San Diego

United States


Organised by

SMi Group Ltd.

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