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Course Description
What are U.S. FDA CGMP expectations / requirements for Post Market Surveilance 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.
Training Agenda
Day 1:
08:00 AM MT (10:00 AM ET) Introduction (personal / course information)
08:20 AM MT (10:20 AM ET) 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
09:40 AM MT (11:40 AM ET) Break / Q&A
10:00 AM MT (12:00 Noon ET) 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
11:15 AM MT ( 01:15 PM ET) Break / Q&A
11:35 AM MT (01:35 PM ET) Session 3 -- FDA’s Voluntary Summary Malfunction Reports
- Medical Device Reporting / Adverse Events (MDRs)
- The Voluntary Summary Malfunction Reports
12:35 PM MT (02:35 PM ET) Session 4 -- CAPA / Trending
- Internal “Complaints” - NCMRs, OOS’
- External Complaint Handling
- CAPA Documentation
- CAPA Trending
01:45 PM MT (03:45 PM ET) Q&A
02:00 PM MT (04:00 PM ET) End, Day 1
Day 2:
08:00 AM MT (10:00 AM ET) Review of Day 1 – Key Points
08:20 AM MT (10:20 AM ET) Session 5 – Failure Investigation, Root Cause Analysis
- Failure Investigation Tools
- Root Cause Analysis – Methods and Tools
- Communication
- Reports
- CAPA Trending
09:30 AM MT (11:30 AM ET) Break / Q&A
09:50 AM MT (11:50 AM ET) 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
11:00 AM MT (01:00 PM ET) Session 7 – Cybersecurity, Especially Post-Market
· Cybersecurity Requirements
· Threat Modelling …
· Post-Market Cybersecurity
12:30 PM MT (02:30 PM ET) Break / Q&A
12:50 PM MT (02:50 PM ET) Session 8 – Project Management Tools ( slides)
· Gantt Chart
· CPM Network Diagram
· PERT Network Diagram
· Post-Market Surveillance Usage
01:40 PM MT (03:30 PM ET) Review / Conclusion; Q&A
02:00 PM MT (04:00 PM ET) End, Day 2
Note: Times are approximate.
Who Will Benefit
- Senior management
- Regulatory Affairs
- Quality Assurance
- Production
- R&D and Engineering
- All personnel involved in the U.S. FDA-regulated medical device development, manufacture, and post market activities. Especially those involved in new medical device / combination product development, non-conformancess and field problems / complaints, line extensions, and incremental product improvements; having to evaluate those changes in light of the DHF / CGMPs, and then document these actions in harmony with the regulations.
Faculty John E. Lincoln
Principal of J. E. Lincoln and Associates LLC
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 36 years experience in U.S. FDA-regulated industries, 22 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files, CAPA systems and analysis.
