This Failure Investigation and Root Cause Analysis training will present a repeatable methodology / defined systems, and simple tools that you can use to trace problems to their source and root cause.
Why Should You Attend :
The most important area audited by the FDA is CAPA. One of the most cited 483 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). Root Cause Analysis is key to many important cGMP activities -- Non-conformance / OOS resolution, Complaint Handling, Adverse Event Reporting and Resolution, Verification and Validation activities, CAPA, Audit corrective and preventive actions -- the list goes on.
Regular 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. Attend this Webinar to understand the 7 key tools to use for root cause analysis and impact assessment and containment. Learn how to define then attack and resolve root problems / causes, not just symptoms.
Areas Covered in the Seminar:
- Importance of Formal Failure Investigation and Root Cause Analysis to CGMPs, ISO 13485, ISO 9001, ISO 14971, and quality improvement initiatives.
- 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.
- Use in CAPA and Validation.
- Effectiveness -- Determining and Monitoring.
Who Will Benefit:
This webinar will provide valuable assistance to all regulated companies that need their in-house personnel trained in simple but powerful tools that will trace problems to their source or root cause. This applies to companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:
- Senior management
- Regulatory affairs
- Quality Assurance
- Production
- Engineering
- All personnel tasked with problem solving
Instructor Profile:
John E. Lincoln, is Principal of J. E. Lincoln and Associates, a consulting company with over 29 years experience in U.S. FDA-regulated industries. 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 including QMS and so+E6ftware 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 CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. John is a graduate of UCLA.
