Post-Market Surveillance and Adverse Event Reporting: Introductory
July 18, 2026 2026-07-20 16:30Post-Market Surveillance and Adverse Event Reporting: Introductory
Post-Market Surveillance and Adverse Event Reporting: Introductory
Build the foundation of post-market surveillance: Medical Device Reporting under 21 CFR Part 803, MedWatch and MAUDE, Corrections and Removals, and drug pharmacovigilance under Part 314.80.
No prior Aleph course is required.
An approved medical product does not end its regulatory life at approval, it barely begins. Every adverse event, complaint and field signal must be captured, assessed, escalated and, when applicable, reported to the agency within exact timelines.
This 16-hour Professional Certificate Course introduces the post-market surveillance landscape, Medical Device Reporting under 21 CFR Part 803 (criteria and 30-day / 5-day timelines), MedWatch and MAUDE (program structure and forms), Part 806 Corrections and Removals, and drug pharmacovigilance under Part 314.80 with ICSR reporting and FAERS.
The Introductory course prepares participants for the Advanced level (RAQ-665-A), where EU MDR vigilance, signal detection, CAPA integration and recall classification are developed in depth.
The Introductory course gives quality, regulatory and vigilance professionals the MDR and pharmacovigilance foundation on which every post-market surveillance system depends.
Participants who meet the course completion requirements receive a Certificate of Completion issued by Aleph University.
Tell us about your goals, audience, and timeline. Aleph University will follow up with information and a custom quote for individuals, teams, or organizations.
Professional development in medical devices, health technologies, regulatory affairs, and quality.
490 Sawgrass Corporate Parkway, Suite 130
Sunrise, FL 33325
United States
Quick Links
© 2026 Aleph University. All rights reserved.
