ARTICLES BY PENELOPE PRZEKOP

• The Growing Value of Quality & Compliance Professionals in Decentralized Pharma

  5/25/2022

  The phrase “the pharma ecosystem” has begun to pop up. Who is best suited to envision, support, and strategize a quality management vision in our current “ecosystem”? Here are some reasons your company and employees should value the unique skillset of these individuals more than ever.

• How To Improve FDA Inspection Readiness & Outcomes By Mining Publicly Available Data

  10/14/2020

  Now 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?

• Navigating The Regulatory Landscape For Therapeutic Radiopharmaceuticals

  1/27/2020

  There have long been numerous global and local regulations for how nuclear materials are transported, compounded, monitored, and dosed for the purpose of diagnostic evaluation. These continue to be applicable for both diagnostic and therapeutic nuclear medicines. However, establishing therapeutic medical claims for nuclear medicines increases the list of regulations that must be followed.

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

  11/12/2019

  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

  7/25/2019

  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?