We are proud to announce the 4th Annual Pharmaceutical Microbiology East Coast Conference
taking place on April 28th - 29th, 2021.
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 leading experts to discuss and analyze the latest advances and challenges within the industry. Network with industry professionals, discuss revisions in regulatory and guidance documents, explore data integrity considerations for conventional and rapid microbiology methods, analyze arising issues with environmental monitoring to best control contamination and gain insight into an industry perspective on automated endotoxin testing and process automation.
Benefits of AttendingPharmaceutical Microbiology East Coast
will discuss the ongoing complications of contamination control in controlled manufacturing environments. Gain essential insight into the microbial monitoring of pharmaceutical grade water systems from Pfizer and Novo Nordisk, discuss the frequent issues encountered in sterility assurance assessments from an active member of the FDA, and reach an expert understanding of risk-based cleaning regimes and operator protocols.
- EXPLORE the latest advancements in robust risk-based disinfection strategies for effective cleaning and microbe elimination
- INVESTIGATE the extensive and complex regulatory landscape alongside the regulators
- DELVE into recent case studies delivered by experts in microbial monitoring and agile contamination control programs
- ATTAIN expert tuition in new quality risk management tools for contamination control and the latest revisions in the US Pharmacopoeia at the post-conference workshops
Our Virtual Conference Platform will deliver the following benefits:
- Live and On Demand speaker content: Get access to the latest strategies and case studies from your market place online!
- Network with all the event attendees: Connect, see who’s attending, chat and share contact details with all online delegates, speakers and sponsors
- Exhibit a Virtual Booth: You can pack your customized booth full of documents, videos and even show who is manning the booth during the event and hosting meetings
- Host & Join Meetings & Socials: Join preferred speaking sessions, host you own meetings and even a virtual Networking social, with in built Zoom functionality
Who should attend
- Validation Managers
- Senior Microbiologists
- Quality Control Managers
- Quality Assurance Experts
- Leaders in Sterility Assurance
- Cleanroom Managers
- Regulatory Affairs Managers
- Production Managers
- Quality Systems Managers
Plus Two Interactive Half-Day Pre-Conference Workshops | Tuesday 27th April 2021
Workshop A: USP Microbiology 2021 - Keeping Up with Standards
Workshop Leader: Donald Singer, Microbiology Expert Committee Chair, US Pharmacopoeia
08.30 – 12.30
Workshop B: Quality Risk Management Tools for Contamination Control
Workshop Leaders: Cheryl Essex, Head of Microbiological Control for Biologics, Sanofi
Jon Williams, Global Proactive Risk Manager, Sanofi
13.30 – 17.00
- Don Singer, Senior Microbiology Technical Consultant, North America, and USP Microbiology Committee Chair 2020-2025, Ecolab
- Fred Ohsiek, Senior Specialist, Cleaning Validation, Novo Nordisk
- Hilary Chan, MS Principal Quality Control Scientist, Takeda
- Jim Polarine Jr, Senior Global Technical Service Manager, Steris Corporation
- Joanny Salvas, Manager, PAT projects, Pfizer
- Johannes Oberdoerfer, Lead Scientist, Rapid Microbiology Methods, Boehringer Ingelheim Pharma GmbH & Co. KG
- John Arigo, Division of Microbiology Assessment Director, FDA
- Kashyap Bhatt, Manager GPV Quality Operations, Takeda
- Lacey Batts, QC Biochemist II, Novo Nordisk
- Laurie Boyd, Senior Microbiologist/Team Leader, Alkermes, Inc.
- Lynne Ensor, Vice President, RCS Head of Global Compliance, Parexel International
- Matts Ramstorp, Professor in Cleanroom Technology, BioTekPro AB
- Maximilian Augustin, Validation Project Manager, Roche Diagnostics Gmbh
- Qiao Bobo, Division Director, FDA
- Rosemary Versteegen, CEO, International Serum Industry Association
- Sean OBrien, QA Director, Contamination Control, Sanofi
- Tony Cundell, Principal Consultant, Microbiological Consulting, LLC
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