Seminar 2014 - 2-day In-person Seminar on “Quality Audits for the Medical Device Industry” at Raleigh, NC

Summary of the workshop:
Quality audits are an important element in checking the health of a Quality Management System (QMS). Audits are one of the most powerful tools that management has to assure on effective QMS.
When you read an FDA Warning Letter do you ask, "Where was the internal audit program?" Why didn't the company find it themselves?
In this seminar participants will look at the various kinds of audits and understand their role. Internal quality audits (1st party) help a company evaluate itself. Customer/supplier audits (2nd party) play a role in an effective supplier management program. Don't forget that you could be the supplier being audited. Independent audits (3rd party) can help provide assurance about the health of a QMS.
Learning Objectives:
This seminar will help you create an effective quality audit program for medical device manufacturing. Your audit program needs two major elements. First, you need a plan to schedule, conduct, report, and close audits. Second, you need qualified people to perform the audits. The seminar explains how to implement the quality audit program elements using examples and exercises that help develop the necessary skills.
Another important part of an audit program is responding to audit non-conformances. This includes correction, investigation, and corrective action. An effective audit program will determine and eliminate the cause of the nonconformity. These methods are important in all three audits types. The seminar provides methods and exercises to help implement these important activities.
Management needs to understand the results from each audit type, which are presented at Management Review. The presentation should use statistical methodology to analyse quality audit reports. The seminar discusses the role of management review and helps you identify the appropriate statistical methodology.
Meet your Expert:
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 year’s experience in quality, operations, and program management in regulated industries including aviation, defence, 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.
RAC Credits: 12
Date: October 30th & 31st, 2014
Event Details: http://bit.ly/QualityAuditsfortheMedicalDeviceIndu...
Location: Raleigh, NC
Venue: Courtyard Raleigh Midtown
Venue Address: 1041 Wake Towne Dr, Raleigh, NC 27609, United States
Registration: Open Enrollment
Delivery: Face-to-Face event
Price: $1295.00
Until September 15, Early Bird Price: $1,295.00
From September 16 to October 28, Regular Price: $1,495.00
Audience: Senior and middle management, Management Representative, Quality Assurance, Quality Engineers, Regulatory Affairs, Supplier Management and Purchasing, Supplier Quality Engineers, Lead Auditors, Audit Team Members.
Course Web Site: https://www.globalcompliancepanel.com/control/~pro...
Organizer:
GlobalCompliancePanel imparts knowledge of best practices in industry to guarantee effective implementation of compliance programs for meeting regulatory demands. The key focus of GlobalCompliancePanel is to provide extensive and quality training for risk management, regulatory compliances, corporate governance and quality management.
Our Achievements:
Over 300 Experts that are Renowned in their Respective Areas
Successfully Trained more than 20,000 Compliance Professionals
A Most Comprehensive Portal for Trainings, Industry Updates and Professional Growth
Having more than 2000 Online Courses
Successfully Completed more than 170 Seminars in US and Globally
Provider:
GlobalCompliancePanel
John Robinson
161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA
Phone: 800-447-9407
Fax: 302-288-6884
Email: support-AT-globalcompliancepanel.com
Website: www.globalcompliancepanel.com