Instructor: John E Lincoln This CAPA training will provide 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. Why Should You Attend:
Repeatable, systematic Failure Investigation and Root Cause Analysis is an often discussed, but little understood discipline among those who could benefit most from its use. The most important area audited by the FDA is CAPA. 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).
This webinar will show how regular, defined and systematic use of a few simple but powerful tools can contribute greatly to reduction of product liability, cost reduction efforts, less chance of recalls, and an improved bottom line.
Areas Covered in the Seminar:
* Elements of a truly "closed loop" CAPA system.
* Accurate Event Description.
* A Sample Failure Investigation Template.
* 7 Powerful Tools for Root Cause Analysis.
* Investigation Detail - Root or Probable Cause.
* Impact -- Often neglected but of major importance.
* Correction, Corrective Action, Preventive Action.
* Effectiveness -- Determining and Monitoring.
* Institutionalize.
Who Will Benefit:
This webinar will provide valuable assistance to all regulated companies (Medical Device, Diagnostic, Pharmaceutical, and Biologics fields).
The employees who will benefit include:
* Senior management
* Regulatory Affairs
* Quality Assurance
* Production
* R&D and Engineering
* All personnel tasked with problem solving
Instructor Profile:
John E. Lincoln , is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 29 years experience in U.S. FDA-regulated industries, 16 years as a full-time 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. 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, conducted workshops and webinars worldwide on all CGMP subjects. John is a graduate of UCLA. more
