ARTICLES BY PENELOPE PRZEKOP
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How To Improve FDA Inspection Readiness & Outcomes By Mining Publicly Available Data10/14/2020
Now that we have years of real-world regulatory outcomes data available, why are we ignoring their power to serve as a corrective lens for our interpretations of the law?
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SOP Remediation: When Reinventing The Wheel Is The Best Approach11/12/2019
When faced with scenarios that demand SOP remediation (outsourcing, mergers, acquisition), repurposing processes, written content, templates, etc., can be the worst possible and most expensive approach when you factor in time, human resources, and long-term outcomes.
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3 Surefire Approaches To SOP Harmonization7/25/2019
We seem to be buried in standard operating procedures (SOPs). So how the heck are companies supposed to make the SOP mountain smaller through harmonization?
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3 Powerful Writing Tips that Will Significantly Improve Your Clinical SOPs4/18/2019
In addition to my career as a pharma industry consultant, I’m a writer. While I don’t claim to be the next Ernest Hemingway, I do consider myself a decent writer. I’ve put in the 10,000 hours of writing Malcolm Gladwell told us it takes to be an expert in his 2008 book, Outliers: The Story of Success . I’ve always had a passion for writing. At 24, I made a serious commitment to become a real “writer.”