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FDAnews Announces — Corrective Action & Preventive Action for Medical Devices: Implementing the Steps to Prevent a Warning Letter Webinar, Feb. 23, 2017
Date:2/17/2017

Corrective Action & Preventive Action for Medical Devices
Implementing the Steps to Prevent a Warning Letter
**An FDAnews Webinar**
Feb. 23, 2017 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/capamd    

Do manufacturers distinguish between corrective action (CA) and preventive action (PA)?

The methods share techniques and tools but they are different and have different purposes. Confusing the methods or lumping them together is a major source of problems.

Join industry expert Dan O’Leary on Feb. 23 when he’ll identify the most frequently cited steps in the corrective and preventive action processes, explain the issues that warning letters reveal and provide information to avoid these problems.

After this 90-minute webinar attendees will:

  • Learn the three parts of the FDA’s corrective and preventive action system
  • Understand the steps in the FDA’s corrective action and preventive action processes
  • Learn the QSIT expectations for each step
  • Review warning letter citations and understand the FDA’s reasoning
  • Understand how to correct similar problems in the QMS
  • Learn how to prevent the problem initially

BONUS: Participants receive a checklist designed to help implement effective corrective and preventive action systems. The checklist addresses each of the steps and includes recommendations for the procedure as well as recommendations for forms and other record keeping.

Register today and implement compliant systems to withstand an FDA inspection and manage efficient and effective improvement.

Meet the Presenter:
Dan O’Leary is the President of Ombu Enterprises, LLC., a company offering training and execution in Operational Excellence, focused on analytic skills; and a systems approach to operations management. Dan has more than 30 years experience in quality, operations and program management in regulated industries including: aviation, defense, medical devices and clinical labs. He has a Master’s Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer and Six Sigma Black Belt; and is certified by APICS in Resource Management.

Who Will Benefit:

  • Quality managers
  • Process owners
  • Investigators assigned to improvement opportunities
  • Quality engineers
  • Manufacturing engineers
  • Supervisors
  • Internal quality auditors
  • Documentation specials

Webinar Details:
Corrective Action & Preventive Action for Medical Devices
Implementing the Steps to Prevent a Warning Letter
**An FDAnews Webinar**
Feb. 23, 2017 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/capamd        

Tuition:
$287 per site

Easy Ways to Register:
Online:     http://www.fdanews.com/capamd                                            
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

Read the full story at http://www.prweb.com/releases/FDAnews/capamd/prweb14080781.htm.


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