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Blog Post by Sheila Gwizdak
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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