Developing Effective Post Market Surveillance and Complaint Handling Requirements (Interrelationship with CAPA, Change Control, Adverse Event Reporting and Recalls)
December 10 - 11, 2024 | US Eastern Time: 10 AM to 4 PM | Central Europe Time: 4 PM to 10 PM
- Faculty: JOHN E. LINCOLN
- Product ID: SEM1655
Learn More
| SEMINAR DESCRIPTION | WHO SHOULD ATTEND | |
Non-conformances, complaint handling, trending, closed-loop CAPA, and other pre- and post-market surveillance systems mandate a repeatable, systematic Failure Investigation and Root Cause Analysis with follow-up. These are often discussed, but little understood disciplines among those who could benefit most from its use. With reason, the most important area audited by the FDA is CAPA -- it assures the FDA that company is in compliance without the Agency constantly auditing it. However, one of the most cited 483 observation is failure to resolve the key underlying problem and close out CAPA documents in a timely manner -- basically an inability to define, locate and resolve the basic problem(s) or root cause(s). Regular, defined, systematic use of a few simple but powerful tools can contribute greatly to reduction of product liability, cost reduction efforts, less chance of recalls, effective post-market surveillance, continuous product improvement, and an improved bottom line. WHY YOU SHOULD ATTEND: A company's compliant complaint, CAPA / trending, and post-market surveillance system assures the FDA of a proactive system with a specific sequence of activities, each building on the other, to enhance patient safety and improve product quality. | This seminar will provide valuable assistance to all regulated companies that need a repeatable methodology / defined systems, and simple but powerful tools for "closed loop" CAPA, including proper failure investigation / root cause analysis and making the fix permanent. This applies to companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:
|
A full capture, investigation, verify/validate, monitor, change control methodology, coupled with accurate root cause analysis is crucial to a "closed-loop" CAPA system, that meets / exceeds CGMP requirements and U.S. FDA expectations. It is also key to many other important cGMP activities -- Non-conformance / OOS resolution, Complaint Handling, Adverse Event Reporting and Resolution, other Verification and Validation activities, Audit corrective and preventive actions, et al. Simple tools and work flow are not understood, disseminated, and used, consistently. Product failures, liability issues, scrap / waste / fall off, and needless recalls result, as evidenced in recent notorious events. The FDA has faulted companies repeatedly for failure to identify, systematically investigate, resolve, and then verify/validate and monitor for resolution of the key underlying problem -- basically an inability to define, locate and resolve the basic problem(s) or root cause(s) -- using a repeatable system. Avoid a "shoot from the hip" approach. Define, then attack, and resolve root problems / causes, not just symptoms, using repeatable, systematic, SOP-defined methods as part of the "closed-loop" CAPA system.
AGENDA
DAY 1 (10 AM to 4 PM)
| DAY 2 (10 AM to 4 PM)
|
Course Directors: JOHN E. LINCOLN
 | John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company. He has over 42 years experience in U.S. FDA-regulated industries, 28 of which have been as a full time, practicing consultant. John has worked with companies from start-up o 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 software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files, CAPA resolutions. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, and 6 chapters in two RAPs textbooks on validation. He has conducted workshops and webinars worldwide. He is a graduate of UCLA. |