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CANCELED Please see the agenda for a complete education list.
CAPA Workshop: Why is My Process Not Working? 
Sponsored by OW CMYK1

Attend the workshop before OMTEC, from 12:00 pm - 4:00 pm Tuesday, June 16 in Session Room 47.

Add the event to your OMTEC registrationor, just choose the CAPA workshop. Registration fee is $489. Confirm your attendance here!

There could be a handful of reasons why your company's corrective and preventive actions (CAPA) process fails to produce results. The issue usually stems from an inability to identify the root cause of the problem and a lack of resources. This four-hour workshop will run attendees through real scenarios and provide actual, implementable solutions that will eliminate the need to repeat the question, "Why is this still not working?"

In line with FDA's inspection strategy, the ultimate purpose surrounding the CAPA subsystem is to collect and analyze information, identify and investigate product and quality problems and take appropriate and effective corrective or preventive action to prevent recurrence. Generally, companies struggle with the CAPA process. This workshop is geared toward the daily realities of administering and using CAPA in an effective, compliant manner. First, attendees will discuss the expectations of CAPA in terms of 21 CFR, Part 820 and ISO 13485:2012. Then, attendees will discuss real-life scenarios. This is an interactive workshop using all of our experiences as the basis for learning.

John Gagliardi shares three reasons why you should attend this workshop.

Workshop Takeaways                                      

  • How to achieve timely CAPA closure using risk management 
  • How to recognize FDA hot buttons
  • Industry best practices
  • The benefits of a group-learning, interactive environment 

Who Should Attend
CAPA decisions cannot be made by one individual or one department. This workshop allows teams to work together and solve problems.

  • Materials/Commodity Management
  • Purchasing
  • Quality Control
  • Supply Chain Management
  • Manufacturing
  • Executive Management

Speaker Bio Prepare for this Workshop
Gagliardi 2015 WEBJohn Gagliardi is President of MidWest Process Innovation, where his success over the past 45 years has arisen from his practical approach to process orientation and business acuity for the medical device and pharmaceutical industries. His career has included active involvement in research and development, quality assurance, training, operations, process architecture, FDA inspections and regulatory affairs. Mr. Gagliardi specializes in building systems in a compliant and “business-ready” manner.

Mr. Gagliardi is a third-party auditor for ISO 13485, 21 CFR, Parts 820 and 211. He is a U.S. Agent and Official Correspondent to over 30 foreign medical device manufacturers and specification developers. MidWest Process Innovation offers training curriculums in Design Controls, Handling FDA Inspections, Purchasing Controls, CAPA, Quality Auditing, cGMP-QSR and ISO 13485:2012.

It is imperative that your company successfully use the CAPA process every day, as it impacts each procedure in the Quality Management System (QMS). CAPA is one of the key elements to a compliant QMS that will lead to improvement (with an ISO focus on continual improvements) and compliance. A robust CAPA process is of the utmost importance to an orthopaedic device manufacturer in an age when recalls are prevalent, warning letters for repeat offenders are on the rise and Medical Device Reporting continues to be a gauge for failure affecting human beings. A process that identifies and eliminates non-conformances and potential non-conformances enables companies to realize not only a cost savings in the short term, but could, more importantly, redefine a company culture centered on far-term accomplishments.

Not every problem or non-conformance requires corrective action, per se. Yet, I continue to notice companies at which every defective that is realized is being captured in a cumbersome CAPA process using formats far too complicated for mere aberrant issues. Whether “full” corrective action is needed varies by the type of device being manufactured, the risks involved with each occurrence and the severity of the outputs.

Mr. Gagliardi highlighted companies' CAPA missteps in a recent BONEZONE article. Do these issues sound familiar?