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05.25.21 -- Are You Approaching LIMS Validation Correctly?


05.25.21 Are You Approaching LIMS Validation Correctly?
 
 
Sanofi wanted to upgrade from an existing batch chromatography process to the BioSMB multicolumn format, then scale up that process to a continuous perfusion run. This case study details the real-world results.
Featured Editorial
By Tim Sandle, Ph.D., Bio Products Laboratory Ltd.
Laboratory information management systems (LIMS) are an established part of larger laboratories. However, different LIMS vary in their scale, functionality, and quality. This article considers the essential validation criteria for LIMS to ensure the system functions as a compliant component in the digital backbone of the modern laboratory.
Industry Insights ....

Dominic Hyde , Stephen Natoli , Alex Nancekievill , Kashif Ghaffar , Jason Osman , Peter Poechlauer , John Mcguire , Todd Andrews , Gabriela Mikhaiel , Jeff Tremain , Lonnie Barish , Matthew Jones , Mike Dingle , Bora Pharmaceuticals , White Paper Alconox Inc , Nidec Group , Natoli Engineering Company Inc , Qa Ajinomoto Bio Pharma Services , Pharma Services , Thermo Fisher , Per Hammer , Natoli Engineering Company , Coperionk Tron , Ajinomoto Bio Pharma , Fisher Clinical , ஆதிக்கம் செலுத்தும் ஹைட் ,

05.11.21 -- FDA Issues Pandemic Remote Inspection Guidance For Drug Manufacturing Facilities


05.11.21 FDA Issues Pandemic Remote Inspection Guidance For Drug Manufacturing Facilities
 
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In this free live webinar, we will provide an overview of the strategy to speed up the migration from a vial to a pre-fillable syringe when developing a vaccine. We will discuss the different packaging characteristics, assess the syringe platform, and present what Stevanato Group can offer to support pharma partners in delivering a safe and effective vaccine.
Featured Editorial
On April 14, 2021, the FDA released a new guidance,
Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency. This article discusses planning, conducting, and concluding a remote interactive evaluation under this guidance and shares how to submit public comments for FDA consideration. ....

United States , Ted Tharp , Paul Magreta , Kate Hammeke , Kurtr Nielsen , Webinar Lonza , Ashwin Gurunathan , August Bioservices , Omara Salman , Stacy Holdread , Andrea Oro , Eleonora Bellissimi , Jeff Tremain , Sylvia Tsengouras , Derek Pendlebury , Xiaojuan Huang , Vincenza Pironti , Kara Faford , Thomaso Brien , Rose Pham , Webinar Cytiva , Neelanjan Sengupta , Isabelle Lafosse , Kimesha Hammett , Rui Teixeira , Bobby Sheng ,