Auditing Quality Systems for FDA & ISO Compliance

(On-site or Virtual Private Group/Company Training)

Date: Your Choice

Location: On-site or Virtual

Who: Your entire company, department, project team, you select

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 (including ISO 13485:2016). 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 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
  
• How to conduct an audit without negatively polarizing an organization, department or individual
  
• 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 (including ISO 13485:2016) & 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

Instructor(s): To be determined based on schedule and your specific needs. All instructors are very experienced and experts in the field being taught. Biographies will be provided and a discussion with the instructor(s) will be arranged so that a proposal can be provided for training that meets your needs.

Duration: Standard course is approximately 8 hours. Customized courses can vary. On-site courses are typically taught in 1 day. Virtual courses can be taught over multiple days, e.g. 2 days for 4 hours/day, etc.

Request a training proposal for your company.