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08.17.21 -- 10 Critical Validation Parameters For Microbiological Experiments

08.17.21 -- 10 Critical Validation Parameters For Microbiological Experiments
pharmaceuticalonline.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from pharmaceuticalonline.com Daily Mail and Mail on Sunday newspapers.

Dominic Hyde , Paul Magreta , Megan Mason , Harry Benson , Webinar Samsung Biologics , Hunter Malanson , Rose Pham , Peter Poechlauer , Eleonora Bellissimi , Lee Allen , Matthew Jones , Herb Crosby , Thermo Fisher , Ken Ball , Hue Rose Pham , ஆதிக்கம் செலுத்தும் ஹைட் , மேகன் கொத்தனார் , ஹாரி பென்சன் , உயர்ந்தது ஃப்யாம் , லீ ஆலன் , மேத்யூ ஜோன்ஸ் , மூலிகை கிராஸ்பி , தெர்மோ மீனவர் , கேன் பந்து , சாயல் உயர்ந்தது ஃப்யாம் ,

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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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 ,

01.21.21 -- Using Production And Postmarket Data To Validate FMEA Assumptions

01.21.21 Using Production And Postmarket Data To Validate FMEA Assumptions

Acepodia s Dr. Sony Hsiao, CEO, and Dr. Mark Gilbert, SVP of R&D, join
Business of Biotech for a discussion on the company s approach to dramatically reducing the cost of cell therapy development, manufacturing, and administration via its oNK, CAR, and ACC candidates. Listen now and subscribe so you never miss an episode.
Featured Editorial
By Mark Durivage, Quality Systems Compliance LLC
One common issue with regulatory agencies and certification bodies regarding failure mode and effects analysis (FMEA) is that organizations are not utilizing production and post-market surveillance data to validate the probability of occurrence and probability of detection assumptions, which leads to inspectional observations and audit findings. ....

Paul Magreta , Sheri Gimigliano , Beth Kendserky , Dan Updyke , Spencer Bolte , James Faust , Albert Cheong , Mariana Curcio , Allison Alix , Eleonora Bellissimi , Gillian Miller , Rose Pham , Hunter Malanson , Timothy Wortley , Patrickm Hutchins , Scott Martin , John Erdner , Debra Barnes , Frederic Baudry , Jeff Sizemore , Seption Group , Article Stevanato Group , Rockwell Automation , Automated Systems Of Tacoma Inc , Pharma Services , Application Note Silverson Machines Inc ,