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Streamlining your Internal Auditing Program for FDA and ISO 13485 Compliance

Summary

  • Develop or update a risk-based internal auditing system that is compliant to FDA cGMP/ Quality System Regulation and ISO 13485
  • 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
  • Understand what makes a good internal audit
  • Understand the skill required for an internal auditor
  • Understand what the FDA must see to verify that you are conducting your internal audits as required

Overview

Internal audits are required by both the FDA and ISO 13485. This seminar will cover how to create a Risk-based, value-added internal auditing system for compliance to FDA and ISO 13485 internal auditing requirements, including ISO 13485:2016.  It will include how to set up and manage the auditing system, how to plan a realistic annual internal audit schedule that covers all the requirements of your company’s quality system, as well as an overview of how to conduct an internal audit, and document the results. This webinar will explain how the principles of risk can be incorporated into your audit program without adding a lot of additional audits, thus reducing your risk of non-compliance. It will discuss the value of a good internal auditing program in reducing compliance risk of all types.

Why should attend?

  • Audit Manager

  • Internal auditor

  • Supplier Auditor

  • Quality Manager

  • Regulatory compliance manager

  • Supplier auditors

  • Quality engineer

  • Quality Consultant

     

Betty Lane

Expert

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 quality system requirements for other area such as Europe and Canada. Betty’s training experience includes over 25 years of training on all areas ISO 13485 and FDA cGMP.

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