Penelope Przekop

Penelope Przekop, MSQA, RQAP-GCP

Penelope Przekop, MSQA, RQAP-GCP and her company, PDC Pharma Strategy, 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-plus 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 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 Novartis, Covance, Wyeth, and Johnson & Johnson. She is the author of Six Sigma for Business Excellence (McGraw-Hill).  Her new book, 5-Star Career, Why You Don’t Have Yours Yet and How to Get It (Productivity Press) launches in late 2020.

Courses Taught