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05.11.21 FDA Issues Pandemic Remote Inspection Guidance For Drug Manufacturing Facilities
Sponsor 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. ....
12.17.20 FDA FY2020 Drug Inspection Observations And Trends
ISR’s Health Panel includes managers, directors, executives, and subject matter experts in clinical development and drug manufacturing who work at pharma companies, service provider companies, and research sites. Members are paid for their time (a 15-minute survey may pay $40, whereas a 45-minute phone interview may pay $150) and they get to choose which research opportunities to participate in. Apply here. Featured Editorial
This article presents the FDA s most recent publication of GMP drug inspection data, which address drug inspections conducted in FY2020. We examine data from FY2020 and evaluate five years worth of trends in drug GMP inspection enforcement. ....