SMi’s 2nd Annual Pharmaceutical Microbiology East Coast Conference

Discussing best practice and techniques to tackle microbial control challenges

Conference: 10 – 11 April 2019

Workshops: 12 April 2019

Location: Battery Wharf Hotel, Boston, USA

Website: www.microbiologyeastcoast.com/PPWL

SPONSORED BY: Associates of Cape Cod, Charles River, bioMérieux, and DuPont

CHAIRED BY: James Drinkwater, Chairman, Pharmaceutical & Healthcare Sciences Society

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. In fact, the value of the rapid microbiology testing market is expected to reach USD 6.2 Billion by 2022, expanding at a CAGR of 7.3% from 2016 to 2022.

Join industry experts to discuss and analyze the latest advances and challenges within the industry. Network with industry professionals, discuss the revision of Annex 1, explore data integrity considerations for conventional and rapid microbiology methods, analyze arising issues with environmental monitoring and gain insight into an industry perspective on automated endotoxin testing and process automation.

Event Hashtag: #SMiPharmaMicroEC

At the 2nd Annual Pharmaceutical Microbiology Conference, you will gain insight into:

Design, validation and implementation of a documented and approved disinfectant programme
Effective use of environmental monitoring data trending
Rapid microbial methods
Challenges with endotoxin control
Advances in sterility assurance technology
Current regulations, challenges and trends in mycoplasma safety testing
A "deep dive" case study of atypical, low-level mold contamination

FEATURED SPEAKERS INCLUDE:

Cheryl Essex, Head of Microbiological Control for Biologic Drugs, Sanofi
Frederic Ayers, Consultant Scientist, Eli Lilly and Company • Christopher Day, Group Leader, ASO Microbiology, Bristol-Myers Squibb
Elia Sanchez, QC Microbiology Senior Manager, Genentech
Clyde Schultz, Adj Professor, University of Calgary and Director Quality Assurance, Celgene
Andrew Bartko, Research Leader, Battelle Memorial Institute

KEY TOPICS FOR 2018 INCLUDE:

Regulatory considerations for contamination control
Revision of Annex 1 and impact on pharmaceutical microbiology
Contamination control strategies and case studies
Microbiological methods
Regulations of endotoxin detection methods
Environmental monitoring
Rapid microbial methods
Sterility assurance
Risk mitigation for mycoplasma and animal sera

Plus 2 half day interactive workshops on Friday, April 12th 2019.

Workshop A: Mold Contamination Challenges - Led by: Microrite Inc

Workshop B: Microbiological Control of GMP using Vapour Phase Hydrogen Peroxide bio-Decontamination – Led by: PHSS & Franz Ziel GmbH

View the full agenda: www.microbiologyeastcoast.com/PPWL

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

EARLY BIRD-RATES