ARTICLES BY PENELOPE PRZEKOP

• 4 Imperatives For Updating Our Clinical Quality Systems Approach For 2022 Pharma

  7/29/2021

  The clinical quality management systems approach developed 20 years ago is not sustainable in the today’s industry because we've seen dramatic industry changes in outsourcing, remote monitoring, the use of electronic systems in clinical research, and more. But how do we update our approach for 2022 pharma? This article examines 4 imperatives, including how to accomplish them.

• 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?

• How Storyboarding Can Bring Clarity To Regulatory Inspection Readiness & Facilitation

  8/25/2020

  Developing 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.)

• 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?

• 3 Powerful Writing Tips that Will Significantly Improve Your Clinical SOPs

  4/18/2019

  In addition to my career as a pharma industry consultant, I’m a writer. While I don’t claim to be the next Ernest Hemingway, I do consider myself a decent writer. I’ve put in the 10,000 hours of writing Malcolm Gladwell told us it takes to be an expert in his 2008 book, Outliers: The Story of Success . I’ve always had a passion for writing. At 24, I made a serious commitment to become a real “writer.”

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

  2/7/2019

  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

  9/11/2018

  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

  7/31/2018

  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

  2/13/2018

  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.