What are U.S. FDA CGMP expectations/requirements for Post Market Surveillance and Complaint Handling.
This webinar 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 in 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 Content
- FD&C Act Section 522
- 21 CFR 822
- EU's MDR Requirements (Articles and Annex)
- FDA Guidance Documents' Recommendations
- Design Control; Risk Management, and Human Factors/Use Engineering Production and Process Controls
- CAPA
- The Risk Management File (ISO 14971) and its role
- The Use Engineering File (IEC 62366-1) and its role
- Expected QMS Records
Course Provider
John E. Lincoln,
Principal Consultant ,
J. E. Lincoln and Associates LLCJohn E. Lincoln is principal of J. E. Lincoln and Associates LLC, a consulting company, with over 33 years’ experience in U.S. FDA-regulated industries and 20 years as a full-time consultant. He 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 including QMS and so+E6ftware validations, ISO 14971 product risk management files / reports, design control / design history files, and technical files. He's held positions in manufacturing engineering, QA, QAE, regulatory affairs, to the level of director and VP (R&D). In addition, Mr. Lincoln has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CGMP subjects. He is a graduate of UCLA.
Who Should Attend
- 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-conformance 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.
