Failure Investigations

PRESS RELEASE
Contact: Michelle Butler
Marketing Manager
FDAnews
703-538-7665 phone
mbutler@fdanews.com

How do manufacturers document failure investigations so that regulators can see they’re on top of the situation? Join Karl Vahey, Associate Director of Manufacturing Quality at Medtronic,on June 29 as he walks webinar attendees through a step-by-step guide to effective root cause analysis.

FALLS CHURCH VA USA – June 8, 2016

Failure Investigations:
Treating the Root Cause, Not the Symptoms

June 29, 2016 — 11:00 a.m. – 12:00 p.m. ET
www.fdanews.com/failureinvestigations                 

Failure investigations are more than must-do quality tasks. They can lead to scrap reduction, rework reduction, cost cuts and process improvements.

It’s good to treat the root cause, not the symptoms.

Join Karl Vahey, Associate Director of Manufacturing Quality at Medtronic,on June 29 as he walks attendees through a step-by-step guide to effective root cause analysis.

Attendees will learn:

·       The importance of a failure investigation

·       The steps in a failure investigation

·       How to use Fault Tree Analysis and Failure and Effect Analysis

·       How to write a good executive summary

·       Practical dos and don’ts of lessons learned from morethan 10 case studies

Register today and learnhow to conduct an effective root cause analysis.

Meet the Presenter:

KarlVahey
Senior Director Manufacturing Quality of Europe and Asia, Medtronic

Karl Vahey is currently the Senior Director Manufacturing Quality with Medtronic.  Karl has 25 years of experience in the medical device industry and has worked in Manufacturing, Quality Assurance, Regulatory Affairs and Quality Systems Compliance. His current responsibilities include overseeing Quality Operations for manufacturing facilities in Asia and Europe.

Who Will Benefit:

Creating the procedures, developing the records, and ensuring compliance is a team effort involving many functions and disciplines. This includes people in the following roles:

·       Quality Managers

·       Quality Engineers

·       Quality Auditors

·       Regulatory Managers

·       Complaint Handling Specialists

·       Data Analysts

·       Adverse Event Specialists

Webinar Details:
Failure Investigations:
Treating the Root Cause, Not the Symptoms

June 29, 2016 — 11:00 a.m. – 12:00 p.m. ET
www.fdanews.com/failureinvestigations                

Tuition:
$287 per site

Easy Ways to Register:
Online:      www.fdanews.com/failureinvestigations          
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.