Polaris Compliance Consultants, Inc. @ConsultPolaris
Polaris Compliance Consultants offer expert GxP & CSV/Part 11 Auditing, SOP & Regulatory Writing, Strategic Consulting, and Training. polarisconsultants.com Joined May 2011-
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In honor of St. Patrick's Day, STOP what you're doing and watch this. I promise you it will be the best 2 minutes of your day. (Speakers up!) ow.ly/E44D50yO5Hh
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Polaris thanks all the content providers who keep our newsletter informative: @CenterWatch @realGovzilla @US_FDA @MHRAgovuk @NCBI @HHSGov Here's a copy: ow.ly/m1Ls50yDWdc
Polaris newsletter comes out this Friday AM. Come for the snark; stay for the content. Subscriber here: ow.ly/NBGT50yDVWM
This is an excellent question. How are sponsors/CROs handling cases in which your monitors cannot perform planned on-site activities due to COVID19?
Polaris newsletter comes out this week. Included: the limitations of using FitBit data to inform healthcare decisions, and the power of the all-important Clinical Inspection Summary. Subscribe and read about it: ow.ly/tDOG50yDVPl
Polaris newsletter comes out this week. Includes helpful tips for FDA inspection: which items you can withhold from investigators and how to review audit trails to find problems before they do. Subscribe and read about them: ow.ly/aYjg50yDVH3
Congratulations, Paul @ivsin!
Happy Birthday to CT dot GOV!
Polaris Compliance Consultants, Inc. retweeted
Check out my latest article: When CROs Commit Scientific Fraud by Purchasing Fake Awards linkedin.com/pulse/when-cro… via @LinkedIn #scientificmisconduct #integritymatters #clinicaltrials
ICH is proposing a complete re-write of E6. Late 2019 ICH Management Committee endorsed the business plan and scope for ICH E6(R3). Turns out E6(R2) caught us up somewhat, but #clintrial tech is just evolving so fast. ow.ly/9hiV50y3sv2
Thanks for all the great content: @Proclinical @FDA_Drug_Info @WHO @DrugInfoAssn @US_FDA @KimberlyCincy @tmprowell You can get your copy here: ow.ly/x86S50y0kZ7
Polaris newsletter comes out this week. Stories include CDER’s message to Congress about drug manufacturing/oversight and Cyber Insurance – do you need it? Say no to FOMO. Subscribe: ow.ly/WEPF50xZXHN
Polaris newsletter comes out this week. Stories include new FDA Q&A webpage and clever uses of eConsent metadata. So subscribe. You know you want to: ow.ly/p0QN50xZXsM
Polaris newsletter comes out this week. Stories include the top 10 medical advances in history and what caught our eye in WHO’s new Data Integrity guidelines. Yep, spillin' all the tea: ow.ly/k9UP50xZP15
Move over #CSV, there's a leaner, less document-intensive process coming! This year, CDRH plans to draft its long-awaited Computer Systems Assurance (#CSA) guidance. ow.ly/WVR650xXfxl
What was the #1 most frequent FDA GMP inspectional observation last year? Hint: it’s always the same one! Can you name it? Via @MCMasterControl ow.ly/MIkM50xRk7X?
Polaris Compliance Consultants, Inc. retweeted
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