FDA Regulatory, Quality and Compliance Seminars and Training

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Validation of Systems Using Artificial Intelligence (AI), Machine Learning (ML), Blockchain and ChatGPT for FDA Compliance

Faculty: Carolyn Troiano ‎ ‎ ‎ ‎ ‎‎ ‎ ‎ |‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ Code: FDB2648

ChatGPT-Assisted Technical Writing

Faculty: Charles H. Paul ‎ ‎ ‎ ‎ ‎‎ ‎ ‎ |‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ Code: FDB3769

How to Best Document the Clinical Evaluation Report (CER) for the CE Mark

Faculty: John E. Lincoln ‎ ‎‎ ‎ ‎ |‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ Code: MD3653

Risk Management for AI in Medical Devices: Insights from FDA’s Life Cycle Management Draft Guidance

Faculty: John E. Lincoln ‎ ‎ ‎ ‎ ‎‎ ‎ ‎ |‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ Code: MD3750

Project Scheduling Techniques for Medical Device Submissions

Faculty: Charles H. Paul ‎ ‎ ‎ ‎ ‎‎ ‎ ‎ |‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ Code: MD3768

Human Error and Management Systems – Designing Errors Out

Faculty: Dr. Ginette Collazo

AI Errors May Be Impossible to Eliminate – What That Means for Its Use in the FDA

Faculty: Dr. Ginette Collazo ‎ ‎‎ ‎ ‎ |‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ Code: FDB1304

Pharma Curriculum Development Using a Learning Management System (LMS)

Faculty: Michael Esposito ‎ ‎ ‎ ‎ ‎‎ ‎ ‎ |‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ Code: FDB2882

Inspection Readiness: Defending Your Use of AI to FDA and Auditors

Faculty: Charles Paul ‎ ‎ ‎ ‎ ‎‎ ‎ ‎ |‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ Code: FDB1603

Statistical Process Control (SPC) and Control Charts - In Accordance with Latest FDA Expectations

Faculty: John E. Lincoln ‎ ‎ ‎ ‎ ‎‎ ‎ ‎ |‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ Code: FDB3551