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03 11 21 -- Critical cGMP Considerations For Electronic Batch Records
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02.23.21 Cleaning Of Multipurpose API Plants: 9 Rules To Follow
Orphan drugs are notorious for their high costs and risk factors, which are attributed to smaller patient pools and higher development and launch costs.
Attend this webinar to learn more about key trends that are causing the rise of orphan drug indications, fast-tracking early development phases that will lead to commercial success, and more!
By Grant Mordue
Cleaning validation continues to be a hot topic during regulatory inspections and industry discussions. The cleaning required in an API plant between one manufacturing process and the next can present a huge challenge, particularly when multipurpose plants are used.
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.
Newsletter | December 22, 2020
12.22.20 The 12 Months Of Quality: Tips For Building A Voluntary QA Culture In A 2021 COVID World
On
The Business Of Biotech, AGTC CEO Sue Washer gives a behind-the-scenes look at the creative measures her company took to serve a geographically dispersed clinical patient population and ensure her company met clinical milestones during the COVID-19 pandemic. Listen now and subscribe so you never miss an episode.
Featured Editorial
By Judy Carmody, Ph.D., Carmody Quality Solutions, LLC
As we close out 2020, which can’t come soon enough, it is fitting to look at how to build a voluntary quality culture in our “new normal” work environment.
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