Compliance of Your Osmometer
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Your lab may be tasked with complying to various Pharmacopeia such as USP chapter 785 (to which there have been recent changes), EP and others. In this session, osmometer user Aashni Shah, Senior Scientist at GSK will talk about their approach to the use of calibrators and controls in their QC release testing. Also, Shweta Nair, Senior Product Manager from Advanced Instruments will clarify the current state of play around the following topics
• New software and hardware developments from AI which aid compliance
• The range of calibration standards and controls offered by AI to aid compliance
• IQOQ offerings
This will be followed by an open panel discussion to get feedback on what the pain points are and how future product developments might help
Aashni Shah, GSK
Aashni Shah is a QC Senior Scientist working within the Pharma Supply Chain function, BioCTL department at GSK, a global pharmaceutical company focusing on vaccine, pharmaceutical, and consumer healthcare development
Shweta Nair, Advanced Instruments
Shweta Nair is the Senior Product Manager, Biotechnology portfolio, at Advanced Instruments, a manufacturer of scientific analyzers that serves the biotech and pharma industries. The company recently launched a portfolio of osmometers that include data integrity features in support of 21 CFR Part 11 and EU Annex 11 compliance.