Data Integrity In Microbiology: Meeting Increasing Regulatory Expectations

Featured

 

DATE

27 August 2020

 

LOCATION

Menara Peninsula Hotel

In light of multiple warning letters highlighting data integrity violations, international authorities – FDA, EMA, PIC/S, WHO, MHRA – published and have draft documents to describe the regulatory expectations of Data Integrity. Microbiological laboratories are directly impacted by these developments, however, the subject of data integrity in the pharmaceutical microbiology laboratory has not been afforded very much attention in terms of regulatory guidance. This workshop will cover the regulatory requirements and present practical experiences on the implementation of data integrity strategies in microbiological testing, in particular bacterial endotoxin testing and microbial identification.

 

Mr. John Dubczak

John Dubczak is the Executive Director, Reagent Development and Pilot Plant Operations for the Microbial Solution Division of Charles River Laboratories. His most recent role was General Manager for the Charleston, South Carolina for the last 20 years. He was responsible for the production and technical operations for the Endosafe® brand of Microbial Solutions. Prior to joining Charles River, John was a long-term employee of Baxter Healthcare Corp., where he developed Baxter’s proprietary LAL formulation and manufacturing process. As a member of the R&D team, he had also developed methods for product testing and explored the clinical applications of LAL. With seven years of Large Volume Parenteral manufacturing experience, he brings an in-depth understanding of issues surrounding all aspects of microbiological testing.

 

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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