ARTICLES BY PENELOPE PRZEKOP

  • Top 5 Strategies To Execute And Document GCP/GVP Vendor Oversight
    Top 5 Strategies To Execute And Document GCP/GVP Vendor Oversight

    Over the last 10 years, the face of clinical research & development (R&D) and pharmacovigilance (PV) outsourcing has dramatically changed. What was a common industry scenario by 2010 — a full-scale operational pharma company utilizing both international and U.S.-based contract research organizations (CROs) to execute clinical investigator site monitoring and data management — has evolved into a new common scenario in 2019.

  • 5 GCP Compliance Mistakes To Avoid With Job Descriptions, CVs, & Org Charts
    5 GCP Compliance Mistakes To Avoid With Job Descriptions, CVs, & Org Charts

    When it comes to GCP audits and inspections, low-hanging fruit says a lot about the tree.

  • 10 Key Ingredients For Small Pharma GCP Quality Systems
    10 Key Ingredients For Small Pharma GCP Quality Systems

    Small to midsize pharmaceutical or biotech companies (small pharma) are enjoying the best of times. However, from a quality systems perspective, it could be the worst of times. Many have weak quality systems, are not following global regulatory authority regulations and/or guidance, or lack the level of documentation required to reconstruct every aspect of clinical trials.

  • 3 Tips To Get The Best Bang For Your Mock Inspection Buck
    3 Tips To Get The Best Bang For Your Mock Inspection Buck

    Many sponsors and CROs conduct mock inspections to determine organizational inspection and audit readiness. Investing in a regulatory mock inspection demonstrates a serious commitment to patient safety, data integrity, and regulatory compliance. It is also a proactive strategy to safeguard financial health, particularly for startups and companies with sparse pipelines.

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.