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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 ,

04.15.21 -- An Introduction To Trending In Environmental Monitoring Programs


04.15.21 An Introduction To Trending In Environmental Monitoring Programs
 
In this
Consumer Reports-style analysis, ISR presents data on 383 service encounters from 123 respondents who have been involved in outsourced drug product projects in the past 18 months. This report will help biopharmaceutical companies make more informed CMO decisions and CMOs optimize operational and marketing strategies. You can access a free preview here.
Featured Editorial
By Crystal M. Booth, PSC Biotech
Trending environmental monitoring (EM) data are a regulatory requirement. However, it is useful in obtaining significant information about the facility. Trends can help determine if your facility is in a state of microbial control and relay the data to facility management in a meaningful format. In this two-part series, I look first at the regulations and guidelines around EM.  ....

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04.01.21 -- Auditing Electronic Batch Records For cGMP Status


04.01.21 Auditing Electronic Batch Records For cGMP Status
 
Sponsor
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Featured Editorial
By Tim Sandle, Ph.D., Bio Products Laboratory Ltd.
This article presents some advice for auditing electronic batch records to assess their cGMP status. This is useful in the qualification stage and essential once the electronic record system is in operation.
Industry Insights
Article ....

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