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, partners with pharma and biotech companies of all sizes to develop risk-based strategic solutions for establishing (or enhancing) clinical and pharmacovigilance quality systems that support growth and ensure long-term compliance. She is a global GXP quality systems/assurance and regulatory compliance consultant with 25+ years of industry experience. Her areas of expertise include strategy development, quality systems and assurance, inspection readiness, and organizational training. She frequently conducts regulatory mock inspections and develops outcomes-based inspection readiness strategies. Przekop has held leadership positions in both Big Pharma and CROs, including Novartis, Covance, Wyeth, and Johnson & Johnson. She is the author of Six Sigma for Business Excellence (McGraw-Hill). Her book, 5-Star Career: Why You Don’t Have Yours Yet and How to Get It (Productivity Press), launches in 2020.