September / October 2021

ISPE Briefs: New APQ Guide on Management Responsibilities & Review

Marcy Sanford
ISPE Briefs: New APQ Guide on Management Responsibilities & Review

The second guide in ISPE’s Advancing Pharmaceutical Quality (APQ) series provides a systematic and proactive approach to quantitatively assessing and advancing leadership systems by evaluating the management responsibilities highlighted in ICH Q10 as well as other key leadership components.

APQ Guide: Management Responsibilities & Review (MRR)The ISPE Advancing Pharmaceutical Quality: Management Responsibilities and Management Review Guide “builds upon the foundation of ICH Q10 and adds other key leadership components such as creating a strong patient/consumer focus and establishing systems and staff for external surveillance, engagement, and benchmarking,” said guide Co-Lead Steven A. Greer, Executive Coach, Speaker and Consultant, Genesis Assist, LLC and ESi, Inc. “This guide provides a practical tool for organizations that want to assess and strengthen their leadership systems to support their pursuit of cultural excellence and ultimately create more value for their patients, shareholders, and employees.”

“Most leaders of pharmaceutical organizations are committed to quality but determining how that commitment positions the organization for success in achieving and sustaining cultural excellence can be difficult,” said guide Co-Lead Michael Grischeau, Director of Data Analytics and Management Review, AbbVie, Inc. “Most scorecards do not include metrics focused on leadership effectiveness so drift can occur without warning signs and the results can be significant: drug shortages, enforcement actions, recalls, dissatisfied patients/consumers, and disengaged organizations. The APQ Guide builds on the framework of ICH Q10 with insights from industry leaders on what strong and effective leadership looks like.”

Part of ISPE’s Advancing Pharmaceutical Quality initiative, (, the APQ Guide Series is aligned with international programs that promote quality excellence, as well as the FDA’s interest in quality management maturity. The ISPE APQ Guide: Corrective Action and Preventive Action was the first in the series and published in 2020. Two future guides in the series will explore (a) change management and (b) process performance and product quality monitoring systems.

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Meet the ISPE Staff Sindy Giron

ISPE Staff Sindy Giron

In each issue of Pharmaceutical Engineering®, we introduce a member of the ISPE staff who provides ISPE members with key information and services. Meet Sindy Giron, Administrative Assistant to Thomas Hartman, President and CEO of ISPE. She is in the Administration Group.

Tell us about your role at ISPE: what do you do each day?

As an Administrative Assistant to Thomas Hartman, my role is to provide administrative support on a daily basis. Some of my responsibilities include assisting with planning and scheduling meetings and coordinating the CEO’s calendar and other activities necessary to ensure success. I provide general support to the ISPE North Bethesda, Maryland, office staff. Additionally, I maintain a consolidated Master Activity Sheet including member engagement plans such as conferences, training, webinars, and related digital experiences. I am responsible for the development of ISPE Leadership Team meeting agendas and support the development of the Staff Engagement Agendas for all staff meetings. I also provide periodic and focused support to the Regula-tory and Training Departments.

What do you love about your job?

I love the work environment and how ISPE employees are always willing to help others to ensure ISPE’s success.

What do you like to do when you are not at work?

I love to spend time with my family and travel.