Overview:
This program is designed to provide participants with:
Understanding and developing an effective Corrective and Preventive Action System
An understanding of a structured problem solving process
Tools and techniques to perform root causes analyses
The use of facts and data to eliminate the use and identification of ineffective solutions.
An 8-Step Process is presented during the program, consisting of:
Identify the Problem
Identify the Team
Contain the Problem
Describe the Problem
Identify Possible Causes
Identify Root Cause
Implement Corrective/Preventive Action
Measure and Monitor Results
Participants are provided with a series of tools and templates that can be used after the training is completed.
The program consists of both tutorial and practical sessions through the use of lectures, workshops, case studies, and role-playing.
Why should you attend?
Since 2010, the U.S. Food and Drug Administration's (FDA's) findings of medical device manufacturers Quality System Regulation (QSR) deficiencies have shown that Corrective and Preventive Action (CAPA), one of the seven subsystems under the Quality System Inspection Technique (QSIT) methodology is by far the most prevalent, accounting for almost one-third of cited violations; a significant number of those citations have led to the issuance of Warning Letters. The expectation of the FDA is the identification of the root cause leading to the issue, its effective elimination, and monitoring to ensure that the actions taken were effective.
The average cost of a Warning Letter remediation effort is estimated at $750,000 to correct the identified deficiencies and includes additional resources for consultants, personnel, remediation of legacy records, etc. This cost estimate does not even include the ramifications of product recalls or holds, cost of not going to market with a new device, or delays in FDA 510(k) or PMA processing as a result of a Warning Letter, and poor publicity. The cost of regulatory noncompliance remediation is, therefore, significantly greater than the cost of compliance. Are you in compliance with the FDA CAPA requirements for medical devices? Do you know how to identify root cause?
Area Covered in the Session
Understanding and developing an effective Corrective and Preventive Action System
An understanding of a structured problem solving process
Tools and techniques to perform root causes analyses
The use of facts and data to eliminate the use and identification of ineffective solutions.
Who will benefit:
This course is developed to provide valuable assistance to all regulated companies that need to understand their software development processes including companies:
Quality Managers and Professionals
Regulatory Managers and Professionals
Compliance Managers and Professionals
Production Management
Manufacturing Engineers
Process Owners
Quality Engineers
Quality Auditors
Document Control Personnel
Legal Professionals
Agenda:
Day One:
Lecture 1: Corrective and Preventive Action
Corrective and Preventive Action Overview
Corrective Action
Preventive Action
The "Closed Loop" System
CAPA Warning Letters
The Need for Systemic Evaluation
Lecture 2: Problem Solving and Root Cause Analysis
Problem Solving Overview
Identify the Problem
Identify the Team
Contain the Problem
Describe the Problem
Day Two:
Lecture 1: Problem Solving and Root Cause Analysis (continued)
Identify Possible Causes
Verify Root Cause
Implement Corrective/Preventive Action
Measure and Monitor Results
Use of a Decision Matrix
Course Review and Wrap-Up
Speaker:
Les Schnoll
Principal , Quality Docs, LLC., USA
Les Schnoll Les Schnoll has extensive experience in quality assurance, quality control, auditing, regulatory compliance, management, and microbiology in the medical device, pharmaceutical, and clinical/pre-clinical industries.
Schnoll is recognized for achievements in developing value-added quality management and regulatory compliance systems. He is recognized by the Medicines and Healthcare Products Regulatory Agency (MHRA) (formerly the Medical Devices Authority) in the United Kingdom to perform assessments to the European Union Medical Device Directive and the European sterilization standards.
Les is the Principal of Quality Docs, LLC, providing quality and regulatory services to the FDA-regulated and Arizona Department of Health-regulated industries. He is also currently an Instructor in the Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Device program in the College of Professional Studies at Northeastern University and a Faculty Associate at Arizona State University, College of Nursing and Health Innovation, in the MS Regulatory Science and Health Safety Program. He was most recently the Vice President, Quality Assurance and Regulatory Affairs with the J.T. Posey Company and has held executive positions at Thermogenesis,
Location: Raleigh, NC Date: September 17th & 18th, 2015 Time: 8:00 AM - 4:30 PM
Venue: Courtyard Raleigh Midtown
Venue Address: 1041 Wake Towne Dr, Raleigh, NC 27609, United States
Price: $1,695.00 (Seminar for One Delegate)
Register now and save $200. (Early Bird)
Until June 30, Early Bird Price: $1,695.00
From July 01 to September 15, Regular Price: $1,895.00
Contact Information:
NetZealous LLC,
DBA GlobalCompliancePanel
161 Mission Falls Lane,
Suite 216, Fremont, CA 94539, USA
USA Phone: 800-447-9407
Fax: 302-288-6884
http://www.globalcompliancepanel.com
Event Registration Link - http://bit.ly/1AEig1Y