ARTICLES BY PENELOPE PRZEKOP
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![two-business-people-GettyImages-1354841430]( "A 3-Point Strategy For Training Part-Time GCP Consultants")
11/17/2022Global biopharma regulations and guidelines require that individuals involved in conducting clinical trials be qualified by a combination of education, training, and experience. The components are straightforward to implement regarding internal employees, but not so clear when it comes to part-time consultants contracted to intermittently execute specific good clinical practice (GCP) tasks. Discover three trips for training independent consultants.
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![Quality Mgt. Science_450x300]( "How Quality Management Science Can Build A 5-Star Company")
10/1/2021The following four concepts based on the science of quality management may serve to shift your mindset while you are considering how to define the company or organization that you, as the leader, deem five-star worthy.
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![Breaking Rocks]( "How To Improve FDA Inspection Readiness & Outcomes By Mining Publicly Available Data")
10/14/2020Now that we have years of real-world regulatory outcomes data available, why are we ignoring their power to serve as a corrective lens for our interpretations of the law?
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![Comic Drawing]( "How Storyboarding Can Bring Clarity To Regulatory Inspection Readiness & Facilitation")
8/25/2020Developing storyboards for regulatory inspection readiness and facilitation is a growing trend, yet the tool is shrouded in mystery for many pharma industry professionals. (Downloadable storyboard template included.)
Penelope Przekop
Penelope Przekop is a corporate quality management expert. Throughout her 30+ year career, she has worked with numerous Fortune 100 pharma companies, including Pfizer, Merck, Lilly, and Glaxo Smith Kline, and held leadership positions at Novartis, Covance, Wyeth, and Johnson & Johnson. She is the founder and CEO of PDC Pharma Strategy, a firm that provides corporate compliance, quality assurance, and pharmacovigilance consulting and services. She is an author whose books include Six Sigma for Business Excellence (McGraw-Hill) and 5-Star Career: Define and Build Yours Using the Science of Quality Management (Productivity Press). Przekop earned a BS in biology from Louisiana State University and an MS in quality systems engineering from Kennesaw State University. She is a graduate of the Smith College Program for Women’s Leadership and the Rutgers University Senior Leadership Program for Professional Women.