Problem Solving and Root Cause Analysis - the Key to an Effective CAPA System at San Diego, CA

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:

1.     Identify the Problem

2.     Identify the Team

3.     Contain the Problem

4.     Describe the Problem

5.     Identify Possible Causes

6.     Identify Root Cause

7.     Implement Corrective/Preventive Action

8.     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: San Diego, CA        Date: July 16th & 17th, 2015        Time: 8:00 AM - 4:30 PM 
Venue: DoubleTree by Hilton Hotel San Diego Downtown

Venue Address:  1646 Front Street, San Diego, California, 92101, USA

Price: $1,295.00   (Seminar for One Delegate)

Register now and save $200. (Early Bird)

Until June 10, Early Bird Price: $1,295.00

From June 11 to July 14, Regular Price: $1,495.00

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

support@globalcompliancepanel.com  

http://www.globalcompliancepanel.com

Event Registration Link - http://bit.ly/1FZd1f7