2 BioPharm International eBook Quality and Regulatory Sourcebook eBook March 2022 www.biopharminternational.com
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QUALITY: ANALYTICS
Assessing the Quality of
CAR-T Cells Using ddPCR
Mark White and Marwan Alsarraj 4
QUALITY: VALIDATION
Contextualizing Computer Validation
Grant Playter 8
QUALITY: CLEANROOMS
In-Use Testing of Cleanroom Garments
Feliza Mirasol 10
REGULATIONS: INSPECTIONS
Remote Inspections—Lessons Learned
James Stumpff and Siegfried Schmitt 12
REGULATIONS: DATA INTEGRITY
How a Lack of Critical Thinking is
Hindering Regulatory Compliance
Calvin Kim 15
The Data Relationship
Felicity Thomas 20
REGULATIONS: SUPPLY CHAIN
A New Route to Pharma GDP
Compliance and Standardization
Courtney Soulsby and Alan Kennedy 24
DSCSA's Next Big Hurdle
Tracy Nasarenko 30
Supply Chain Considerations
for Ensuring Quality
Susan Haigney 33
COMPENDIAL COMPLIANCE
Standards Facilitate
Continuous Manufacturing
Jennifer Markarian 37
Quality and Regulatory
Sourcebook March 2022
Contents
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