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A Committee Built Upon Excellence

2023 Committee of the Year - Advancing Pharmaceutical Quality

The ISPE International Honor Awards program serves as a platform to celebrate the dedication and excellence of our members and their contributions to the pharmaceutical industry. The prestigious 2023 ISPE International Honor Award for Committee of the Year recognizes the remarkable achievements of ISPE's committees, councils, task teams, or communities of practice steering committees.

The 2023 Committee of the Year: A Remarkable Journey

APQ logoISPE recognizes the Advancing Pharmaceutical Quality (APQ) Committee as the 2023 International Honor Award winner for Committee of the Year. This exceptional group of ISPE members set a mission to do the following:

Develop a program that serves to encourage and accelerate the pharmaceutical industry’s continual improvement toward quality excellence.

Over the past decade, the APQ team has been instrumental in raising ISPE's profile with regulators worldwide. From 2017 to 2022, they developed, pilot-tested, and published the Advancing Pharmaceutical Quality (APQ): A Quality Management Maturity Program in a series of five guidance documents, explains Carol Winfield, ISPE Senior Director of Regulatory Operations and Advancing Pharmaceutical Quality ISPE Staff Project Manager. Notably, the team has maintained strong, committed leadership since the start, a true testament to their unwavering dedication to serving ISPE.

The APQ program is described as an industry-led quality management maturity program that builds upon the four ICH Q10 elements and Cultural Excellence. Unlike simple assessment programs, it employs an "Assess, Aspire, Act, and Advance" framework. Carol highlights the program's uniqueness and effectiveness. It starts with assessing and aspiring through quantitative and qualitative tools to diagnose gaps and identify improvement targets, followed by acting and advancing toward excellence.

A Year of Achievements: Committee of the Year

The APQ team's success extends far beyond their impressive guidance documents. They have actively contributed to the industry by publishing numerous articles in PE Magazine, developing blog posts, conducting webinars, and presenting at various conference sessions. Their collaborative spirit extends to partnerships with fellow ISPE Committees, making them a cornerstone of the regulatory volunteer group structure.

The APQ team is chaired by Tami Frederick, Senior Director of Corporate Quality Systems and Cultural Excellence with Perrigo. The APQ Team is targeted to launch their APQ training program in 2024, among their many achievements. Carol added that the APQ Guide series represents an entirely new product line for ISPE and is unlike other products on the market.

Honoring the Advancing Pharmaceutical Quality Committee Members

Maria Amaya
Lead External Advocacy North America (Quality Policy)
Genentech, A Member of the Roche Group
Lori Rae Chelemedos
Founder/Principal Consultant
Pac-Side LLC
Andrew Denny
Executive Director, Predictive Quality
Bristol-Myers Squibb
Joseph C. Famulare
Famulare Consulting LLC
Tami J. Frederick
Senior Director, Corporate Quality Systems & Cultural Excellence
Bethany Glyde
Head of Global Quality Compliance
Marci L. Goldfinger
Global Director, Quality Strategy & Porfolio
Michael Grischeau
Director of Data Analytics & Management Review
AbbVie Inc
Harry Jeffreys
VP Pharmaceutical Quality Operations
Bausch + Lomb Inc - Bridgewater, NJ
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Robert Hill Koger, IV
VP, Global Pharmaceutical & Lens Care Quality Operations, Internal Manufacturing
Bausch + Lomb Inc
Christine M. V. Moore, PhD
Executive Director, Quality Systems & Compliance
Organon LLC
Christopher John Potter, PhD
CMC Pharmaceutical Consultant
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Frank Scarcia
Director, Quality & Compliance
Bausch Health
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Wilian Silveira
Scientific Director
Novo Nordisk A/S
Hugo Ta
Gilead Sciences
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Paul Tarashuk
Head Quality Management Systems
Johnson & Johnson
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Nelson Webb
External Engagement Leader
Procter & Gamble
Carol M. Winfield
Senior Director, Regulatory Operations
Christian Wölbeling
Executive Industry Advisor
Körber Pharma Software GmbH

These accomplishments represent just a fraction of the APQ team's extraordinary journey. They are a shining example of how ISPE members catalyze positive change in the pharmaceutical industry. We thank you for your contributions to ISPE.

Celebrating Excellence

As we celebrate the outstanding achievements of the 2023 International Honor Award for Committee of the Year, the APQ Committee, we extend our gratitude to all ISPE members who contribute their time, expertise, and passion to advancements in pharmaceutical engineering.

The hard work and commitment of the APQ Committee not only advances the industry but also inspires others to follow in their footsteps. Your dedication and innovation set the standard, and your influence is apparent in the continuous growth of the APQ team. Together with ISPE, let’s continue to work collaboratively, inspire one another, and drive growth in the world of pharmaceutical engineering.

On behalf of ISPE, we extend our heartfelt congratulations to the 2023 Committee of the Year, APQ Committee. ISPE looks forward to honoring remarkable ISPE Committees doing exceptional work in 2024.

Learn more details about current and past ISPE International Honor Award recipients. 

Learn More about ISPE’s APQ Program