FDA Regulatory, Quality and Compliance Seminars and Training

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Beyond Digital Batch Records: Managing FDA and EU GMP Documentation While Preserving Data Integrity

Faculty: John E. Lincoln | Product ID: MD3752

OTC Monograph Reform and OMUFA II: What FDA’s Modernized OTC Framework Means for Manufacturers

Faculty: Meredith Crabtree ‎ ‎ ‎ ‎ ‎‎ ‎ ‎ |‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ Code: FDB1418

Annex 22 and AI Governance for GMP: Human Review, Model Monitoring, and Change Control

Faculty: Carolyn Troiano ‎ ‎ ‎ ‎ ‎‎ ‎ ‎ |‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ Code: FDB2849

QMSR Device Records: Structuring DDF, MDF and Related Relationships for Inspection Readiness

Faculty: José Mora ‎ ‎ ‎ ‎ ‎‎ ‎ ‎ |‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ Code: MD1382

AI-Assisted Post-Market Surveillance and Signal Detection: What Regulators Will Still Expect Humans to Defend

Faculty: Meredith Crabtree ‎ ‎ ‎ ‎ ‎‎ ‎ ‎ |‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ Code: FDB1417

AI in GMP: What the FDA Is Already Expecting - Before You Ask

Faculty: Dr. Ginette Collazo ‎ ‎ ‎ ‎ ‎‎ ‎ ‎ |‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ Code: FDB1306

Pharma 4.0 Focus Data Integrity by Design - Newer Approaches and Technologies to Cost Effective 21 CFR Part 11 Compliance

Faculty: Carolyn Troiano ‎ ‎ ‎ ‎ ‎‎ ‎ ‎ |‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ Code: FDB2649

GMP Laboratory Data Integrity in 2026: Practical Strategies for FDA and MHRA Inspection Readiness

Faculty: Meredith Crabtree ‎ ‎ ‎ ‎ ‎‎ ‎ ‎ |‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ Code: FDB1416

Digital Quality Metrics and AI/ML Analytics: Building a Continuous-Improvement Framework that Aligns with Regulatory Expectations

Faculty: Carolyn Troiano ‎ ‎ ‎ ‎ ‎‎ ‎ ‎ |‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ Code: FDB2847

Reclassification of Software Automated Medical Devices

Faculty: José Mora ‎ ‎ ‎ ‎ ‎‎ ‎ ‎ |‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ Code: MD2289