ARTICLES BY PENELOPE PRZEKOP

  • 3 Surefire Approaches To SOP Harmonization
    3 Surefire Approaches To SOP Harmonization

    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?

  • 3 Powerful Writing Tips that Will Significantly Improve Your Clinical SOPs
    3 Powerful Writing Tips that Will Significantly Improve Your Clinical SOPs

    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.”

Penelope Przekop

Penelope Przekop

Penelope Przekop, MSQA, RQAP-GCP, is a quality management systems, assurance, and compliance consultant with 25+ years of experience in pharmaceutical GxP global quality systems with a key focus on clinical development, data management, and pharmacovigilance. Her areas of expertise include quality systems, quality assurance, regulatory compliance, inspection readiness, training, and strategic planning. Przekop earned a B.S. in biological sciences from Louisiana State University and an M.S. in quality assurance/systems engineering from Kennesaw State University. She has held leadership positions in both Big Pharma and CROs, including Johnson & Johnson, Wyeth Pharmaceuticals, Novartis, and Covance.