ISPE Briefs: New Guide Promotes Cultural Excellence

Cultural excellence is not a project, but an ongoing commitment by leaders and individuals to model desired behaviors and hold others accountable to behavioral standards.

Guide Co-Lead Nuala Calnan, CEO, BioPharm Excel Ltd.

Cultural excellence affects company performance in all areas: quality, operations, and supply chain. A culture of excellence understands patient safety as paramount, as it recognizes quality not as an operational burden or compliance requirement, but a necessity that allows companies to make decisions that best benefit the patient.

Guide Co-Lead Erika Ballman, Associate Director Corporate Quality Systems, Perrigo Company Plc.

The APQ Guide: Cultural Excellence provides a quality management framework for assessing and advancing an organization’s culture of quality by evaluating the following aspects: leadership and vision; mindsets and attitudes; Gemba and employee engagement; leading quality indicators—measuring what matters; proactive oversight, review, and reporting; cultural enablers; and critical third-party partnerships.  

To our knowledge, the ISPE Cultural Excellence APQ Guide would be considered the first of its kind in combining industry best practices, a cultural excellence framework with rich content in each dimension, inclusion of key cultural enabling behaviors for employee and leader levels, and an effective Assess, Aspire, Act, Advance model for practical development of action plans.

Calnan.

The ISPE APQ Guide: Cultural Excellence is the fifth and final guide in the APQ Guide series that seeks to improve the state of pharmaceutical quality and ensure sustainable compliance. To learn more about APQ Guides and other ISPE Guides, visit ISPE.org/publications/guidance-documents

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Meet the ISPE Staff: Tina Li

In each issue of Pharmaceutical Engineering®, we introduce a member of the ISPE staff who provides ISPE members with key information and services. Meet Tina Li, Training Manager, Professional Development.

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

Each day is a different day for me depending on what’s going on that week. If there’s a week full of training courses, I ensure that my team members and I are ready to facilitate the courses that we’re assigned to. Training days consist of me being present during the training session by fielding attendee questions, troubleshooting technical issues, launching applications, and ensuring that the training is running smoothly for everyone. These are usually an all-day event or a half-day event over the course of 2–4 days.

Behind the scenes of a training session or during a non-training week, I go through my emails and get myself organized for the day. I like to set my intentions early in the morning so that I know what actions I need to take to accomplish my goals. Some days are busier than others, but I adjust ac-cordingly to what requires my attention. Besides facilitation, I also manage our email communications, CEU [continuing education unit] certificates, and virtual course creation.

What do you love about your job?

I love that I’m able to help others achieve their professional development goals to go further in their careers. I also love that I’m able to collaborate with people from all over the world and hearing about their experiences and knowledge in the industry.

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

I’m spending time with my husband and my son. I am a first-time mom, so trying to navigate motherhood has been a new adventure for me. I like to be active as much as I can by going on walks and doing some strength training. Lately, I’ve been trying to hit 10,000 steps a day and recently picked up Pi-lates. I’m also a big foodie, so I like to try new cuisines around the area and I also enjoy cooking, as I feel that food is a common ground that brings peo-ple together.