DUBLIN, Dec. 19, 2023 /PRNewswire/ — The “Medical Devices: Developing Effective Post Market Surveillance and Complaint Handling Systems” course has been added to ResearchAndMarkets.com’s offering.
This course will examine Section 522 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as well as appropriate articles/Annexes of the EU’s MDR, which require manufacturers to conduct postmarket surveillance at the time of approval or clearance or at any time thereafter of certain class II or class III devices.
Section 522 is implemented in 21 CFR 822. This formal postmarket surveillance is the active, systematic, scientifically valid collection, analysis, and interpretation of data or other information about a marketed device. A more generalized “post market surveillance”/complaint handling is also a requirement under the device CGMPs, 21 CFR 820, -.100 – CAPA, and -.198 – Complaints. Data collected under post-market surveillance helps to address important public health questions on the safety and effectiveness of a device, often resulting in improvements in device design and manufacture. Similar requirements exist in the EU’s MDR, as part of the final “Clinical Phase”.
Why Should You Attend
Global companies must meet US FDA 21 CFR 820 (The QSR) requirements in order to sell such devices in the US, no matter where they are manufactured. These companies must pass FDA compliance inspections (audits) to 21 CFR 820. One of the key components of these device CGMPs is addressing post-market use issues and complaints/CAPA.
The FDA expects companies to have effective programs in place to capture post-market problems/non-conformances, react to minimize risk to users/patients, and use such data for product improvement. With certain devices, the FDA mandates such controls. How does failure to comply result in adulterated products, 483 Observations, Warning Letters, and worse.
What are the key components of a CGMP-compliant post-market surveillance and complaint-handling system? Where does Medical Device Reporting/Adverse Events fit into such a system? This two-day seminar will provide suggested and mandated approaches, and the answers to these and other related questions.
RAPS – This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.
Course Agenda
Day 1:
Session 1 – US FD&C Act Section 522 and 21 CFR 822
“Postmarket Surveillance under Section 522 of the Federal Food, Drug, and Cosmetic Act”, Guidance, dated October 2022
21 CFR 822 – Implementing Sec. 522 of the FD&C Act – The Law/Requirements – Class II and III Devices
Session 2 — US FDA’s Post Approval Studies (PAS) Requirements
PAS Requirements and PMAs
PAS Orders
PAS Protocols
Interim and Final PAS Reports
Report Evaluations
Session 3 — FDA’s Voluntary Summary Malfunction Reports
Medical Device Reporting/Adverse Events (MDRs)
The Voluntary Summary Malfunction Reports
Session 4 — CAPA/Trending
Internal “Complaints” – NCMRs, OOS’
External Complaint Handling
CAPA Documentation
CAPA Trending
Day 2:
Session 5 – Failure Investigation, Root Cause Analysis
Failure Investigation Tools
Root Cause Analysis – Methods and Tools
Communication
Reports
CAPA Trending
Session 6 – Risk Management and Human Factors
Patient Hazard/Risk Management per ISO 14971:2019
QMS/System Level
File/Review (Benefit/Risk)
Narrative/Descriptive Information
Hazards, FTA, D-, P-, U-FME[C]A + Normal
FDA Use/Human Factors Requirements
Use Engineering Process – 9 stages – IEC 62366-1
Session 7 – Cybersecurity, Especially Post-Market
Cybersecurity Requirements
Threat Modelling .
Post-Market Cybersecurity
Session 8 – Project Management Tools ( slides)
Gantt Chart
CPM Network Diagram
PERT Network Diagram
Post-Market Surveillance Usage
For more information about this training visit https://www.researchandmarkets.com/r/l0soq0
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