ComplianceOnline

The CAPA Trap or Common Problems and Pitfalls

Instructor: Jeff Phillips
Product ID: 700914
  • Duration: 60 Min

recorded version

$249.00
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
Last Recorded Date: Jun-2008

Training CD / USB Drive

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

Customer Care

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Email: customercare@complianceonline.com

Read Frequently Asked Questions

The following webinar will cover common CAPA problems across industries and how to avoid them.

Description

This webinar will provide valuable assistance to all regulated companies that need to have CAPA systems as mandated by the FDA.

One of the most important areas of any quality system in the pharmaceutical or medical device world is the CAPA system. Some systems are more automated and computer driven while others are paper based. No matter what type or brand of system one uses the goal remains the same, to have an appropriate and effective Corrective and Preventive Action program. To attain this goal one must be careful of common traps. These traps may result in 483 observations, warning letters or worse. Ironically, it is often the diligent companies that fall into these traps. The following webinar will cover common CAPA problems across industries and how to avoid them.

Areas Covered in the seminar:

  • FDA’s expectations of a CAPA system.
  • Are electronic systems always better than paper?
  • Did I use root cause analysis?
  • Is it really the ROOT cause?
  • Effects of cross-referencing documents.
  • The metric used to measure CAPAs may be the enemy.
  • When criteria should be used to initiate a CAPA.
  • Are there other systems that conflict or confuse the CAPA system?

Who will benefit:

This webinar will provide valuable assistance to all regulated companies that need to have CAPA systems as mandated by the FDA. These industries include but are not limited to medical device, pharmaceutical, biotechnology and combination device companies.The people that will benefit include but are not limited to:

  • Anyone in production involved with the CAPA process
  • QA managers/directors and personnel
  • Information Technology managers and personnel
  • Validation specialists
  • Consultants
  • Quality system auditors
  • Regulatory managers/ supervisors/ personnel
  • QE managers/ supervisors/ personnel
  • Laboratory supervisors and Managers

Instructor Profile:

Jeff Phillips, has over 12 years experience in the pharmaceutical and medical device industries. He is a principal consultant and co-owner of Atzari Consulting LLC, a company committed to excellence in the pharmaceutical, medical device and biotechnology industries. Jeff has been involved with and remediates dozens of CAPAs in the medical device and pharmaceutical industries, including those involved in warning letter and consent decrees as well as their remediation.

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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