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July 24th 2024

Quality Considerations for Using AI in Bio/Pharma

By Felicity Thomas, Susan Haigney

In the second episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, vice-president, Technical, at Parexel, discuss the quality requirements needed when incorporating AI in bio/pharmaceutical development and manufacturing.

Quality Considerations in Changing Excipient Providers

By Felicity Thomas, Susan Haigney

Latest Videos

Audits, Inspections, and CDMOs

Audits, Inspections, and CDMOs

Ask the Expert: Commenting on Draft Regulations

Ask the Expert: Commenting on Draft Regulations

Ask the Expert: Questions about Real-World Evidence and Supply Chain Security

Ask the Expert: Questions about Real-World Evidence and Supply Chain Security

Ask the Expert: Studies for Extractables and Leachables

Ask the Expert: Studies for Extractables and Leachables

Ask the Expert: Identity Testing on a Final Product

Ask the Expert: Identity Testing on a Final Product

Ask the Expert: Adventitious Contamination Control

Ask the Expert: Adventitious Contamination Control

Ask the Expert: Quality Control Units

Ask the Expert: Quality Control Units

Ask the Expert: EU Data Protection

Ask the Expert: EU Data Protection

Ask the Expert: Product Inspection, Part Two; Automated Product Inspection and Cold Chain Considerations

Ask the Expert: Product Inspection, Part Two; Automated Product Inspection and Cold Chain Considerations

Ask the Expert: Complying with 21 CFR 211.110

Ask the Expert: Complying with 21 CFR 211.110

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