Call for Participants: Defining Quality Intelligence (QI)

George Kwiecinski and Zephaniah C. C. Odidika, in collaboration with other authors,and under their affilatiomns with NYU Tandon School of Engineering and The University of Scranton, Kania School of Management, in collaboration with Marywood University, have launched a confidential have launched a confidential, cross-industry practitioner study under their institutional affiliations at

The study aims to produce the first peer-reviewed academic definition of Quality Intelligence (QI) as a discipline within regulated industries.

Why This Study, Why Now

A useful example of measuring word and term frequency comes from conference agendas. For repeating conferences, the topics discussed and the vocabulary and keywords used signal where the field is moving. See here a recent PDA Week 2026 session analysis breaking down the top terms. That work was a key catalyst for needing sentiment and qualitative-based answers to further research, which this study is designed to capture.

Building on Prior Work

This study builds on the authors' past publications, including:

• The Foreign Inspection Gap: FDA GMP Oversight of U.S. Drug Imports, 2014, 2024, Journal of Pharmaceutical Innovation (Springer Nature)
• PDA Whitepaper #1: Prevalence of AI in FDA Correspondence, open for PDA community rating for 45 days, then archived on the GKS site
• PDA Week 2026 Session Analysis

A Note on Independence

KeyPedia™, a product under the Global Key Solutions suite, is a multifaceted data tool used by industry, including for quality and regulatory activities, for data and diligence. While this announcement is posted on the GKS announcements page as a formal communication of the existence of this research, GKS and KeyPedia do not sponsor nor financially affiliate with this research in any way. All published research is public, and the authors agree to maintain confidentiality of respondent identifiers.

The authors are affiliated with both GKS / KeyPedia and the research, and that dual affiliation is disclosed openly here.

How to Participate

Complete the survey embedded below, or reach the corresponding author directly to discuss.

Who Should Participate

Those learning about or involved in quality in life sciences in any capacity (all role types). Specific categories exist for Quality Assurance leaders, Regulatory Affairs leaders, Compliance officers, Operations leads, ex-FDA professionals, consultants, and Vice Presidents and Directors of Quality across pharma and medical devices.

Why Participation Matters

For all of the reasons above, this research helps further industry advancement, going beyond the published deliverable itself. The authors' past work has been published and has helped start a broader conversation around what topics and agendas should and could be covered at conferences, what practitioners are genuinely interested in, and how the field defines its own vocabulary. Your participation contributes to the first formal academic definition of Quality Intelligence as a discipline within regulated industries.

George Kwiecinski and Zephaniah C. C. Odidika have launched a confidential, cross-industry practitioner study under their institutional affiliations at NYU Tandon School of Engineering and The University of Scranton, Kania School of Management, in collaboration with Marywood University.

The study aims to produce the first peer-reviewed academic definition of Quality Intelligence (QI) as a discipline within regulated industries.

Why This Study, Why Now

A useful example of measuring word and term frequency comes from conference agendas. For repeating conferences, the topics discussed and the vocabulary and keywords used signal where the field is moving. See here a recent PDA Week 2026 session analysis breaking down the top terms. That work was a key catalyst for needing sentiment and qualitative-based answers to further research, which this study is designed to capture.

Building on Prior Work

This study builds on the authors' past publications, including:

• The Foreign Inspection Gap: FDA GMP Oversight of U.S. Drug Imports, 2014, 2024, Journal of Pharmaceutical Innovation (Springer Nature)
• PDA Whitepaper #1: Prevalence of AI in FDA Correspondence, open for PDA community rating for 45 days, then archived on the GKS site
• PDA Week 2026 Session Analysis

A Note on Independence

KeyPedia™, a product under the Global Key Solutions suite, is a multifaceted data tool used by industry, including for quality and regulatory activities, for data and diligence. While this announcement is posted on the GKS announcements page as a formal communication of the existence of this research, GKS and KeyPedia do not sponsor nor financially affiliate with this research in any way. All published research is public, and the authors agree to maintain confidentiality of respondent identifiers.

The authors are affiliated with both GKS / KeyPedia and the research, and that dual affiliation is disclosed openly here.

How to Participate

Complete the survey embedded below, or reach the corresponding author directly to discuss.

Who Should Participate

Those learning about or involved in quality in life sciences in any capacity (all role types). Specific categories exist for Quality Assurance leaders, Regulatory Affairs leaders, Compliance officers, Operations leads, ex-FDA professionals, consultants, and Vice Presidents and Directors of Quality across pharma and medical devices.

Why Participation Matters

For all of the reasons above, this research helps further industry advancement, going beyond the published deliverable itself. The authors' past work has been published and has helped start a broader conversation around what topics and agendas should and could be covered at conferences, what practitioners are genuinely interested in, and how the field defines its own vocabulary. Your participation contributes to the first formal academic definition of Quality Intelligence as a discipline within regulated industries.