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02.18.21 -- 7 Rules For Properly Interpreting Control Charts

02.18.21 7 Rules For Properly Interpreting Control Charts

With the spread of SARS-CoV-2 (COVID-19) intensifying, scientists, together with pharmaceutical companies, are reinventing the approach of how to bring life-saving drugs to market. Attend this webinar to learn more about bringing life-saving drugs to market faster without impacting product quality, safety, or efficacy and the impacts and comparisons of classic platforms vs. new-generation platforms. And more!

By Mark Durivage, Quality Systems Compliance LLC
It is time to consider augmenting your validated production processes, including processing, packaging, and labeling, with continuous process monitoring using control charts to ensure continued compliance with established specifications and requirements. ....

Kyle Zingaro , Scott Patterson , Cathy Zhao , Samsung Biologics , George Siu , Allison Alix , Adam Christensen , Ranjana Singh , Liang Fang , Mitchell Gonzales , Anton Paar Bioindenter , Annabel Igonin , Clean Technology Inc , Services Inc , Case Study Asahi Kasei Bioprocess America Inc , Article Seeq Corporation , Nuaire Inc , Thermo Fisher , Jenifer Mains , West Pharmaceutical Services , Pfizer Centreone Contract , Pfizer Centreone , Anton Paar United , Anton Paar , Asahi Kasei Bioprocess America , கைல் ஜிங்கரோ ,

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 ,