ARTICLES BY PENELOPE PRZEKOP

• A 3-Point Strategy For Training Part-Time GCP Consultants

  11/17/2022

  Global 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.

• How Quality Management Science Can Build A 5-Star Company

  10/1/2021

  The 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.

• 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.)

• 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?

• 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.