Penelope Przekop, MSQA, RQAP-GCP
Penelope Przekop, RQAP-GCP, is a Quality Management Systems, Assurance & Compliance Consultant with 25 plus years of experience in Pharmaceutical GXP Global Quality Systems with key focus in clinical research and development, data management, computer systems validation, and pharmacovigilance. Her areas of expertise include quality systems quality assurance, regulatory compliance, inspection readiness, training, and strategic planning for quality.
Penelope earned a BS in Biological Sciences from Louisiana State University and an MS in Quality Assurance/Systems Engineering from Kennesaw State University. She has held leadership positions in both big pharma and Contract Research Organizations, including Johnson & Johnson, Wyeth Pharmaceuticals, Novartis, and Covance.
She is the author of Six Sigma for Business Excellence (McGraw-Hill), is a past columnist for Pharmaceutical Manufacturing Magazine, and frequent contributor to the Clinical Leader Newsletter. In addition, she is a frequent speaker on topics of quality management systems, regulatory compliance, and overcoming obstacles in both business and life through the application of quality management principals and strategies. Her 25-plus years of experience with big pharma, CROs, and smaller niche companies includes Johnson & Johnson, Wyeth/Pfizer, GlaxoSmithKline, Lilly, Novartis, Covance, IQVIA, ICON, ProPharma, Otsuka, Medimmune, Alexion, Acorda, Daiichi, Vertex, BeiGene, CenTrak, and many more.

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