Each year, the PDA Letter editors and the Editorial Committee identify the top articles published that year based on reader interest and select the one that best encapsulates PDA’s mission of connecting People, Science and Regulation®.
The award is given to the author(s) at the Awards Ceremony, held each year at the PDA Annual Meeting. The 2021 honor was awarded to the article:
The Modern Quality Professional Development Tool
Part 1: Developing a Capability Matrix for Product Quality Leaders
Part 2: The Case Studies
Part 3: Using the Scoring System
Authors: Stephan Krause, PhD, Adele Chambers, Ryan Courtney, Darrin Cowley, and Anthony Mire-Sluis, AstraZeneca
In Part I of their three-part article, “The Modern Quality Professional Development Tool,” the authors describe the tool they created to frame a vision of the quality organization AstraZeneca aspires to achieve. “Developing a Capability Matrix for Product Quality Leaders” explained how the MQP tool uses relevant data, tools and analytics to make sound judgments in pursuit of the true root cause in any issue, including an individual’s lifelong learning journey. Anthony Mire-Sluis, SVP, Head of Global Quality, AstraZeneca, said, “The MQP program has not only identified the capabilities necessary but provides the relevant training and experience to achieve its aims…[and] is having a big impact on the success of the Quality organization.”
Using the Product Quality Leader (PQL) job function, Part II: “The Case Studies” demonstrated how the team used the MQP tool to develop and support “capability uplifts” for both individuals and teams. The case studies illustrated how capability target levels were set for the categories relevant to the role and how the level descriptions were revised to fit PQL-specific job tasks, increasing the flexibility of resource allocation within the Quality organization.
Part III: “Using the Scoring System” discussed how the authors devised a scoring system to identify capabilities and how they used those scores when planning job-specific capability uplifts. The PQL scoring was performed using “half levels” (e.g., 2, 2.5, 3), which allowed for greater flexibility in scoring and provided a more graded approach to monitoring improvement. Adapting this tool to job functions allowed development of clear objectives regarding the capabilities needed to uplift and helped identify short- and long-term capability gaps for future planning.
Article of the Year
PDA congratulates the authors on receiving the 2021 Article of the Year Award! We appreciate their sharing their knowledge to help improve and maintain high-quality standards in the industry.
||“The Modern Quality Professional Development Tool, Parts I, II & III”
||Stephan Krause, PhD; Mariam Khan; Callum Chapman; Rob Gaglione; Andy Spasoff; Anthony Mire-Sluis, AstraZeneca
||“Industry Must Move Away from Dye Ingress Test”
PTI – Packaging Technologies & Inspection
||“Lifecycle Approach Wipes Away Cleaning Validation Concerns”
Takeda Pharmaceutical Company
||“New Approach Suggests Continuous Lyophilization is Possible”
||Pieter-Jan Van Bockstal, Ghent University;
Jos Corver, RheaVita; Thomas De Beer, Ghent University
|| “Formalizing a Risk Assessment for Excipients”
Merck KGaA, Darmstadt, Germany