PODCAST · science
Your Pharmaceutical Quality Friend
by Amir Zarrinhaghighi
A podcast that touches on different regulatory and good practice guidances, as well as pharmacopoeial documents.
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ISPE Digital Validation Good Practice Guide
Based on the sources provided, Digital Validation Tools (DVTs) are software programs or systems designed to replace traditional paper documentation methods in the life sciences industry, crucial for managing activities like requirements, test execution, and results, while maintaining robust audit trails. The ISPE Good Practice Guide: Digital Validation offers practical, risk-based best practices for defining, implementing, and managing these tools within a regulated environment, exploring key concepts such as data integrity (ALCOA++), culture change, and integration with other systems. Adopting DVTs presents challenges related to implementation, governance, system integration, and regulatory adherence, but offers significant benefits, including enhanced data integrity, improved efficiency, streamlined audits, cost savings through paper reduction, and maintaining compliance with regulations like FDA 21 CFR Part 11 and EU Annex 11, often leveraging principles from ISPE GAMP® 5.
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ABOUT THIS SHOW
A podcast that touches on different regulatory and good practice guidances, as well as pharmacopoeial documents.
HOSTED BY
Amir Zarrinhaghighi
CATEGORIES
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Your Pharmaceutical Quality Friend currently has 1 episodes available on PodParley. New episodes are automatically indexed when they're published to the podcast feed.
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A podcast that touches on different regulatory and good practice guidances, as well as pharmacopoeial documents.
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Your Pharmaceutical Quality Friend has 1 episodes. Check the episode list to see recent publication dates and frequency.
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Who hosts Your Pharmaceutical Quality Friend?
Your Pharmaceutical Quality Friend is created and hosted by Amir Zarrinhaghighi.
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