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.
12.15.20 Cleaning Process Development: Time To Clean Studies & The Cleaning Assurance Level For Pharmaceutical Products
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 be $40, whereas a 45-minute phone interview may be $150) and they get to choose which research opportunities to participate in. Apply here.
Featured Editorial
By Ruijin Song and Andrew Walsh, Center for Pharmaceutical Cleaning Innovation (CPCI)
A simple time-to-clean study can provide a rapid and efficient way to evaluate the behavior of a product during cleaning and obtain a reasonable estimate of the actual amount of time needed to achieve acceptable cleaning.