Navigating The Evolving Regulatory Landscape of Pharma Microbiology

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DATE

11 - 12 June 2019

 

LOCATION

Sheraton Petaling Jaya Hotel

This seminar is designed specifically for leaders/operators working in the Microbiology Environment, to understand the current regulatory requirements, data integrity and how importance is data accuracy in posing risk to the patient safety as well as the advance technologies which have been developed and how do they supersede the pitfalls of traditional methodologies, such as BET gel-clot and phenotypic microbial identification system and tips to optimize your current process efficiency and productivity.

 

Mr. Alan Hoffmeister

Alan Hoffmeister has extensive experience with the bacterial endotoxins test and involved in all aspects of the assay, including the design and development of BET-specific instrumentation and software. He has directed workshops and training courses and lectured internationally on a variety of BET-related topics, including LAL methodologies, system qualification, product validations, 21 CFR Part 11, process analytical technologies (PAT) and BET regulatory affairs. He has also contributed to the development of many BET protocols, technical sheets and monographs for domestic and international organizations.

 

Dr. Emily Cheah

Dr Emily Cheah received her PhD in pharmaceutical technology from the National University of Singapore. A registered pharmacist, Dr. Cheah is currently the Managing Director of Charles River Laboratories Singapore (Microbial Solutions division). In current role, she oversees site operations , development of technical services at the Singapore site and evaluates strategic technology development within the Microbial Solutions division. She is also part of Charles River’s Global Data Integrity Compliance Plan working group.

  

Who should attend: Microbiologists, Lab Technician, QC / QA Managers

 

For more information, please contact : SThis email address is being protected from spambots. You need JavaScript enabled to view it. or call +65-6742 6007

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