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Training Agenda
Post Market Surveillance & Complaint Handling Course Agenda
Day 1
FDA postmarket surveillance, PAS requirements, MDRs, complaints, and CAPA
Introduction
- Personal / course information
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
Failure investigation, risk management, human factors, cybersecurity, and project tools
Review of Day 1 - Key Points
- Review of major Day 1 concepts and takeaways
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
- Gantt Chart
- CPM Network Diagram
- PERT Network Diagram
- Post-Market Surveillance Usage
Medical Devices Post Market Surveillance and Complaint Handling Systems Course Description
RAPS: This course has been pre-approved by RAPS as eligible for up to 12.0 credits towards a participant's RAC recertification upon full completion.
What is U.S. FDA CGMP expectations / requirements for Post Market Surveillance and Complaint Handling.
This seminar 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 requirement 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 in addrssing post-market use issues and complaints / CAPA. The FDA expects companies to have effective programs in place to caputure post-market problems / non-conformances, react to minimize risk to users / patients, and use such data for product imporvement. With certain devices, the FDA mandates such controls. How does failure to comply result in adulterated product, 483 Observations, Warning Letters, and worse. What are 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.
Who Will Benefit
This course is ideal for professionals involved in the development, manufacture, and post-market activities of U.S. FDA-regulated medical devices, including:
- Senior Management – overseeing compliance and product safety.
- Regulatory Affairs – ensuring adherence to FDA regulations and guidance.
- Quality Assurance (QA) – managing compliance, audits, and corrective actions.
- Production – implementing compliant processes and monitoring product quality.
- R&D and Engineering – developing new devices, combination products, line extensions, and incremental improvements.
It is especially beneficial for personnel handling:
- New product or combination product development
- Non-conformances, field complaints, and post-market issues
- Evaluating product changes in accordance with the Device History File (DHF) and Current Good Manufacturing Practices (CGMPs)
- Documenting actions to meet regulatory requirements
💡 Stay ahead of regulatory expectations, improve product safety, and reduce compliance risks.
🚀 Enroll now to master post-market surveillance and complaint handling for medical devices!
✅ Frequently Asked Questions (FAQ)
1. Who should attend this course?
Ideal for QA/QC personnel, regulatory affairs specialists, R&D engineers, process engineers, and anyone involved in post-market activities for medical devices.
2. What will I learn?
Participants will learn to design and implement effective post-market surveillance (PMS) and complaint handling systems, investigate complaints, analyze trends, mitigate risks, and ensure regulatory compliance with FDA, ISO 13485, and EU MDR requirements.
3. Is prior experience required?
No prior experience is required, though knowledge of quality systems or medical device regulations is helpful.
4. How does this course help with audits?
The course teaches best practices for maintaining audit-ready documentation, investigating complaints, and implementing PMS systems that comply with FDA and ISO requirements.
Course Instructor
Meet Your Faculty
Faculty
John E. Lincoln
John E. Lincoln is an internationally recognized FDA regulatory compliance, medical device quality systems, and validation expert with more than 40 years of experience in the life sciences industry. He specializes in FDA QMSR, ISO 13485, Design Controls, Software Validation, Process Validation, Risk Management (ISO 14971), 21 CFR Part 11, Data Integrity, and Medical Device Cybersecurity. John has trained thousands of professionals worldwide and is a respected author and conference speaker, helping pharmaceutical, biotechnology, and medical device organizations achieve regulatory compliance, improve product quality, and prepare for successful FDA inspections.
