ARTICLES BY PENELOPE PRZEKOP

  • SOP Remediation: When Reinventing The Wheel Is The Best Approach

    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.

  • 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

    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.