The CAPA Trap or Common Problems and Pitfalls

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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