ComplianceOnline

Webinar on Risk-Based CAPA (Corrective and preventive action) Systems

Instructor: John E Lincoln
Product ID: 701663
Training Level: Intermediate to Advanced
  • Duration: 90 Min

recorded version

$299.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

$500.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556

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Read Frequently Asked Questions

This CAPA training Webinar will teach how to evaluate CAPA systems for compliance and integrate risk management and capture all sources of problem and close the loop by closing out the CAPA documents in a timely manner.

Why Should You Attend:
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 Risk based CAPA Webinar to get the above answers. We will discuss how to capture all sources of problems; how to resolve the key underlying problem and close out CAPA documents in a timely manner; and "close the loop" -- feeding CAPA data into other affected documents, plant sites, or corporate QA/RA. Where are the common disconnects? What are field reports telling us? Are we listening and responding? How can we as a company benefit in ways other than compliance?

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 will provide valuable assistance to all regulated companies that desire methods to evaluated CAPA systems for compliance. Once recognizing the most common industry problems and likely system failure sources / locations, targeting those areas in internal audits, performing a gap analysis, and then putting in place the necessary corrective and preventive actions on the CAPA system. Use a simple question to see if you've drilled down enough. This information 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 complain 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 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 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.

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