This Advanced CAPA training webinar will teach how to evaluate CAPA system for compliance along with highlight the common problems and likely system failure sources and how to proactively address these by various methods like internal audits, GAP analysis.
Corrective and Preventive Action (CAPA) continues being a major source of 483 observations. Companies claim to have fully functioning CAPA systems, often fully automated under one of several COTS QMS software programs readily available. Yet the FDA finds the situation to be otherwise. What are the key issues today -- the latest U.S. FDA findings / 483 observations? How can companies proactively address these? What part does systems entropy play in affecting a once compliant CAPA system? What are the key points to evaluate a system's compliance?
Attend this webinar to know methods to evaluate CAPA systems for compliance. Recognize the most common industry problems and likely system failure sources / locations, and how proactively these can be targeted by internal audits, performing a gap analysis, and then putting in place the necessary corrective and preventive actions on the CAPA system.
Areas Covered in the seminar:
- What is the FDA looking for?
- The 7 key elements of a compliant CAPA system.
- Most likely areas for system breakdowns.
- 10 CAPA objectives your company must meet.
- Problems with the CAPA "satellite programs".
- The constant battle against system 'entropy' -- and why!.
- Monitoring effectiveness -- integration of corrective / preventive action.
Who will benefit:
This webinar applies to personnel / companies in the Pharmaceutical, Medical Device, Diagnostic, and Biologics fields. The employees who will benefit include:
- Senior management
- Regulatory Affairs
- Quality Assurance
- Production
- Engineering
All personnel involved in the complaing handling, non-conforming material, out-of-specification, failure investigations, root cause analysis, trending, supplier qualification, customer service / communications, of regulated medical products.
Instructor Profile:
John E. Lincoln, is Principal of J. E. Lincoln and Associates, a consulting company with over 28 years experience in U.S. FDA-regulated industries. 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 CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. John is a graduate of UCLA.
