BOSTON - Jan. 25, 2021 - Six key presentations will be covered at the 2021 East Coast Pharmaceutical Microbiology Conference by Boehringer Ingelheim, FDA/CDER, Microbiological Consulting, LLC, STERIS Corporation, FDA and Parexel sessions, the presentations will cover sterility regulation and guidance, microbial risk based detection, monitoring water systems and contamination control.

The conference brochure has been updated, download online to see the full agenda and speaker line-up www.microbiologyeastcoast.com/PR2

1. - Manufacturing facility assessments during COVID Pandemic
Commander Qiao Bobo, Division Director, Office of Pharmaceutical Quality, FDA/CDER

2. Emergency Use Authorization: Understanding a Regulatory Strategy Weapon Used to Battle a Pandemic, covering:
Case studies: Application of EUA authority to combat COVID-19
Lynne Ensor, Vice President, RCS Head of Global Compliance, Parexel

3. Live, Stressed, and Dead Microorganisms – Their Role in Microbial Test Method Validation
Dr. Tony Cundell, Principal Consultant, Microbiological Consulting, LLC

4. A Risk Based Cleaning and Disinfection Program
Jim Polarine, Senior Technical Service Manager, STERIS Corporation

5. Common Issues in The Sterility Assurance Assessment
John Arigo, Director, Division of Microbiology Assessment, FDA

6. ENDOTOXIN TESTING SPOTLIGHT SESSION - Automating Endotoxin water monitoring at Boehringer Ingelheim with Endosafe® Nexus™ – A business and validation perspective
Johannes Oberdörfer, Scientist, Rapid Microbiology Methods, Boehringer Ingelheim

This event is ideal for those who are interested and work as 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.

For more information on the conference visit www.microbiologyeastcoast.com/PR2

Sponsored by Microcoat
For sponsorship enquiries contact Alia Malick on +44 (0)20 7827 6164 or amalick@smi-online.co.uk

For media enquiries, contact Simi Sapal on +44 (0) 20 7827 6000 or ssapal@smi-online.co.uk

SMi's 4th Annual Pharmaceutical Microbiology East Coast Conference
Conference: April 28th – 29th, 2021
Workshops: April 27th, 2021
Virtual Conference: Online Access Only
www.microbiologyeastcoast.com/PR2

Contact
Simi Sapal
SMi Group