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Sheila Gwizdak

Blog Post by Sheila Gwizdak

Sheila GwizdakNov 20, 2024 5:57:18 PM3 min read

Moving Through Clinical Development and Operations Obstacles on the Path to Commercialization

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Sheila GwizdakNov 14, 2024 11:24:31 AM4 min read

Key Takeaways from Halloran’s CORE Program: Advice for Clinical Leaders: Driving Quality, Innovation, and Engagement in Modern Clinical Trials

“I always walk away rejuvenated and inspired,” Malachi Bierstein, Chief Commercial ...
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Sheila GwizdakJun 18, 2024 12:21:00 PM2 min read

Quality Equation: 4 Key Components to Enable Drug Development Success

Click Here to Watch "The Quality Equation: Four Essential Components to Enable Drug ...
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Sheila GwizdakJun 13, 2024 1:45:00 PM1 min read

Inspection Readiness Methodology: Failure to Plan is a Plan to Fail

Watch Halloran’s Inspection Readiness Webinar Here A Health Authority inspection of a ...
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Sheila GwizdakMar 7, 2024 12:14:00 PM7 min read

Quality Governance and Evolution of Quality Management Review 

Quality governance can be defined as an overarching framework that provides assurance of ...
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Sheila GwizdakJul 6, 2023 3:44:00 PM6 min read

Halloran’s Feedback on FDA’s Electronic Systems, Records, and Signatures Guidance

Recently at CORE West – a Clinical Operations Retreat for Executives produced by Halloran ...
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Sheila GwizdakApr 20, 2023 3:30:00 PM5 min read

Establishing a Culture of Quality: What Every CMO Should Know

Leaders at biopharma companies often ask us, “What is a culture of quality and how do you ...
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Sheila GwizdakJun 19, 2020 4:46:00 PM8 min read

Ways to Adapt your Inspection Readiness Framework in a COVID-19 World

Although much has changed in the landscape of clinical trials because of COVID-19, the ...
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Sheila GwizdakNov 19, 2019 2:04:00 PM2 min read

Five Tips for Implementing Quality as a Culture in Your Organization

Last week, I led an engaging discussion at BioLabs San Diego on the concept of “quality ...
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Sheila GwizdakMay 17, 2019 11:40:00 AM8 min read

4 Key Ingredients Of A Robust Risk Management Framework

This article was originally published on May 16th, 2019, in Clinical Leader.
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