Course Description:

  • Do you want to understand how to do efficient and effective internal and supplier audits that meet all the requirements of your external auditors, but also add value to your company?
  • Are you confused by all the requirements and guidance documents for medical device quality management systems and are tired of wading through all the regulatory language they contain?
  • Do you need to train new auditors for your medical device quality management systems or to audit your suppliers?
  • Do you need to improve the training of your internal and supplier auditors so that they add value to these audits?

This course will address these key questions and also include:

  • An easy to understand presentation of the auditing process as well as the requirements to audit under ISO 13485 and the FDA Quality System Regulation (cGMP).
  • Discussions on auditing skills and hands-on auditing exercises.
  • Review of the requirements for Quality Management Systems (QMS) for both the FDA (QSR/cGMP) and ISO 13485.
  • Best practices for creating and managing a value-added auditing process that will meet both company business needs and regulatory requirements.
  • Steps to set up and manage an audit system that complies with these requirements and is risk-based so that your company makes the most efficient use of auditing resources for both internal and supplier audits.
  • Interactive exercises to reinforce the fundamentals of conducting and documenting quality system audits.

This seminar has been designed for those who conduct internal and supplier audits and manage an audit process for company audits. Auditing principles taught in this seminar will be based on ISO 19011:2011 guidelines for auditing management systems.

Learning Objectives:

Upon completing this course, participants will:

  • Understand the basic requirements of FDA cGMP/ Quality System Regulation and ISO 13485 which are the basis for what must be audited in your internal audit program
  • Be able to develop or update an internal auditing system that is compliant with FDA cGMP/ Quality System Regulation and ISO 13485, yet makes efficient use of company resources
  • Understand how to manage an internal audit system
  • Understand the difference between internal and external audits
  • Learn how the internal auditing system can add value to your quality system and your company
  • Learn how using a risk-based process can make your audits more efficient and effective
  • Learn how an effective audit system can be an integral part of continuously improving your quality system and your company
  • Understand what makes a good internal audit
  • Understand and have a chance to practice the skills required for an internal or supplier auditor
  • Understand and have a chance to practice how to write effective audit non-conformances
  • Understand what the FDA must see to verify that you are conducting your internal audits as required

Who Will Benefit:

This course is designed for people who perform or manage audits of a medical device quality management system, including internal and/or supplier audits. Both 21 CFR 820 Quality Systems Regulation (cGMP), and ISO 13485 and Quality Management Systems auditing will be covered.

  • Senior quality managers
  • Quality professionals
  • Regulatory professionals
  • Internal or supplier auditors
  • New internal or supplier auditors
  • Audit managers
  • Managers

Topic Background:

Both FDA Quality System Regulation (QSR) and ISO 13485 require that companies do internal audits. However, because the FDA does not look at the content of internal audits, some companies do not get feedback on the true effectiveness of their internal audit system from the FDA during FDA inspections. ISO 13485 auditors do look at internal audits, but are sometimes more interested that you define your audit process to meet the requirements of the standard and not how well you are following the details of your process. Both require that you define auditor training as required, but some companies just requires reading the company’s procedure, and this is not sufficient for your company or most external auditors will look for more than this.

Course Outline:

Day One (8:30 AM – 4:30 PM) Day Two (8:30 AM – 4:30 PM)

Registration Process: 8:30 AM – 9:00 AM

Session Start Time: 9:00 AM

Overview of ISO 13485 Requirements and Reasons for Internal Audits

  • Course Overview
  • Introductions – Interview Exercise
  • Overview of ISO 13485 and FDA Quality System Regulation (cGMP)
  • General Quality System Requirements for Medical Devices
  • Document and Records Control
  • Management’s Responsibilities Including Management Review
  • Provision of Resources Including Human Resources, Training, Facilities and Work Environment
  • Provision of Products and Services: How Do You Provide Products and Services to Your Customers
  • Exercise on Provision of Product and Services – What Issues Has Your Company Had
  • Monitoring, Measurement and Improvement: How Do We Make Sure Everything is Running Well or Fix it if it is Not (Including Product and Process Monitoring, Complaints, Corrective and Preventive Action and Internal Audits)
  • Exercise on Application of Requirements
  • Q&A

Principles and Practices of Auditing

  • The Purpose of Auditing
  • The Difference Between Internal and External Audits
  • Audit Planning
    • The audit manager
    • How to create an audit schedule
    • Tracking audit performance
  • The Audit Process and Our Procedures
    • Audit preparation and planning
    • Check lists
    • Audit notice
    • Opening meeting
    • The audit
    • Specific items to check in various areas
    • Comments and nonconformities
    • Audit report
  • How to Say Things Properly on Audit Paperwork
  • Exercise on Writing Nonconformities
    • Corrective actions
    • Closing the audit
  • Practice Audits
  • What the FDA Can Ask For Concerning Internal and Supplier Audits
  • Q&A

Meet Your Instructor

Betty Lane
Founder and President of Be Quality Associates, LLC

Betty Lane has over 30 years’ experience in medical device quality assurance and regulatory affairs. She is the founder and president of Be Quality Associates, LLC, a consulting company helping small and medium sized medical device and diagnostic companies implement and improve their quality systems. Her work enables companies to manage their business in compliance with FDA and ISO 13485 requirements, as well as managing quality system requirements in other locations such as Europe and Canada. Her background in digital systems engineering enables her to facilitate compliance with design controls and software validation. Her areas of expertise include training, auditing, supplier management, document and records management, design controls, and software validation.

Ms. Lane’s training experience includes over 25 years of training on all areas of ISO 13485 and FDA cGMP in companies where she worked, and for AAMI, ASQ biomedical division, and ASQ sections. She has taught courses in medical quality and regulatory affairs at Northeastern University, Boston, MA. Ms. Lane is active in her local section of the American Society for Quality and is also a member of the Association for the Advancement of Medical Instrumentation (AAMI), The Society of Women Engineers and the IEEE. Betty has degrees in engineering from Rensselaer Polytechnic Institute, and an MBA from Northeastern University.

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