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Fremont Street

Auditing Quality Systems for FDA & ISO Compliance 2008

• Date: Tuesday, October 21, 2008
• Location: Excalibur Hotel & Casino, Las Vegas, Nevada, USA

Overview:
 
Internal auditing and vendor auditing are extremely important compliance activities in the avoidance of FDA enforcement actions and are cited repeatedly in FDA Warning Letters to manufacturers. Notified bodies also verify that internal and vendor audits have taken place when inspecting for ISO registration, CE Mark approval, or the CMDCAS requirements of Health Canada. Internal audits are required by both the FDA Quality System Regulation and by ISO 13485:2003. Be aware that Notified Bodies have access to your internal and vendor audit reports when performing their registration and surveillance audits. This course will provide an understanding of auditing concepts and techniques when auditing medical device manufacturers for compliance to quality systems such as; FDA QSR (21 CFR Part 820), ISO 13485:2003 and CMDCAS. Vendor auditing will also be discussed during this course. Training will cover auditing techniques for quality systems designed to meet FDA, ISO and CMDCAS requirements. This course will be beneficial to new auditors, experienced auditors wishing a refresher, and companies anticipating or expecting to be audited or inspected. It is recommended for QA, RA, R&D, and management of both device manufacturers and vendors to device manufacturers.

What you will learn:

• Auditing Techniques, pre-audit, during the audit, post-audit
  
• How to report audit observations so deficiencies can be corrected
  
• Objective vs. Subjective reporting
  
• Writing accurate audit reports that minimize company liability exposure
  
• Interacting with personnel in a positive environment to obtain accurate information and prevent or minimize any destructive negative impressions or feelings
  
• What Management should look for and review in an audit report
  
• Role of checklists in an audit and how to create an effective checklist
  
• Differences when auditing for compliance to FDA QSR , ISO 13485 & CMDCAS
  
• Auditing vs. FDA Inspections (esp. QSIT) vs. Notified Body Inspections
  
• Auditing specific elements, i.e. Design Control, CAPA, Process & Production Controls, Software, Management, etc.
  
• Auditing the quality system documentation vs. auditing the quality system implementation
  
• Vendor Audits vs. internal audits
  

Benefits of Attending:

• Learn auditing skills
  
• Comply with FDA, ISO & CMDCAS (Canadian) internal auditing requirements
  
• Correct deficiencies before FDA or your Notified Body finds them
  
• Ability to document quality system compliance
  
• Turn audits into positive vs. negative experience for employees and managers
  
• Management will receive more accurate, dependable audit information
  
• Ability to demonstrate & document training
  

Abbreviated Outline:

• A. Course Introduction
  
• B. Brief History & Overview of National & International Standards
  
• C. Introduction – The Process Approach
  
• D. Auditing Overview
  
• E. Workshop Example: Audit Planning
  
• F. Audit Checklists
  
• G. Workshop Example: Audit Checklist
  
• H. Workshop 1: Audit Planning & Checklist
  
• I. “The Audit”
  
• J. Analysis of Findings
  
• K. Workshop Example: Audit Analysis
  
• L. Workshop 2: Analysis of Findings
  
• M. How to Report Audit Findings
  
• N. Workshop 3: Rate & Report Findings
  
• O. Seminar Evaluation & Test

Speakers: Corrine Bonfiglio, Rich Basler

Rich Basler co-authored a two part article discussing ISO 13485:2003 that appeared in Medical Product Outsourcing:

Jan/Feb 2004 Article Part 1 "The Arrival of ISO 13485:2003" (172 KB)

Mar/April 2004 Article Part 2 "Implementing ISO 13485:2003" (138 KB)

Registration & Additional Information : Airfare Discounts, Pricing, Discounts, Continuing Education Units Awarded, Speaker Biographies, Past Participants, Sights to see in the area.

On-line Registration Form Register on-line to reserve your seat now!