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Preparing A Framework For Artificial Intelligence And Machine Learning Validation A 3-Step Approach

Preparing A Framework For Artificial Intelligence And Machine Learning Validation A 3-Step Approach
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United statesPetere bakerJennifer roebberPeter bakerUniversity hospital of walesInternational medical device regulators forumTechnical university munichEuropean medicines agencyDrug administration staffCardiff universityLive oak quality assuranceUniversity of miami miller school medicineInspection convention pharmaceutical coMachine learning in softwareDevelopment of drugGood machine learning practice

Not All Plate Counting Technologies Are The Same

While rapid microbiological methods have advanced, most microbiology lab tests remain reliant upon assessing microbial growth on agar plates.

Tim sandleTechnology europeDigital colony countingData integrityCompliance with drugTest dataSystematic approachAutomated colony counting systemsPharmaceutical sciencePharmaceutical technology europeAutomated countingBacterial colony forming units

Increase In FDA Inspections Whistleblower Complaints Heightened Compliance Scrutiny

We are seeing a significant increase in manufacturing facility inspections by the FDA and other health authorities globally. We are also seeing an.

Christopher fanelliArif nooraniDavid ludlowRaj paiLisa monacoSidley austinUs department of justiceFederal foodCosmetic actWarning lettersImport alertsFalse claims actQuality systems regulationsDeputy attorney general lisa monacoAssistant attorney general kennethData integrity

Attributable Data Integrity in Modern Biopharma Using ALCOA Principles

This article is the first in a five-part series providing contemporary, practical, and useful examples of data integrity within each of the five.

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The Data Integrity Body of Knowledge Expands with New Pending Guidances

Some of the contemporary guidance documents for data integrity in biopharmaceuticals and medical devices, both released and in draft, are explained.

United statesUnited kingdomInternational society for pharmaceutical engineeringInspection coExpert committee on specifications for pharmaceutical preparationsEuropean unionWorld health organization guidanceInternational conference on harmonisationDrug administrationWorld health organizationEuropean commissionRegulatory agencyInspection conventionEuropean medicines agencyHealth canadaExpert committee