Streamlining Your Internal Auditing Process

Instructor: Betty Lane
Product ID: 703448
  • Duration: 60 Min

recorded version

1x Person - Unlimited viewing for 6 Months
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Training CD

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Read Frequently Asked Questions

This webinar will cover creating of a value-added internal auditing program that is compliant to FDA cGMP/ Quality System Regulation and ISO 13485. It will include how to set up and manage the auditing system as well as how to conduct an internal audit and document the results and any nonconformities. It will discuss the value of a good internal auditing program.

Why Should You Attend:

  • Does your current auditing program assure that you are meeting all FDA quality and regulatory requirements, such as labeling and premarket clearance?
  • Does it assure that you are meeting all European and Canadian requirements, if you sell products in those areas?
If not or if you do not know, this webinar will explain how these are incorporated into your audit program without adding a lot of additional audits.

This webinar will cover how to create a value-added internal auditing system including how to plan a realistic annual internal audit schedule that covers all the requirements of your company’s quality system.

Learning Objectives:

  • Understanding the value of internal audit to your company
  • Understanding internal vs. external audits
  • Streamlining your audit process
    • Auditor training
    • Audit planning
    • Audit process
    • Follow-up and closure
  • Understanding what you need and do not need to show the FDA about your internal audits.

Areas Covered in the Webinar:

  • Develop or streamline an internal auditing system that is compliant to FDA cGMP/ Quality System Regulation and ISO 13485
  • Manage an internal audit system
  • Difference between internal and external audits
  • How the internal auditing system can add value to your quality system and your company
  • What makes a good internal audit
  • Skill required for an internal auditor
  • What the FDA must see to verify that you are conducting your internal audits as required

Who Will Benefit:

  • Audit Managers
  • Prospective Audit managers
  • Current Internal auditors
  • Prospective Internal auditors
  • Quality Management
  • Regulatory Compliance Managers
  • Supplier Auditors
  • Quality Engineering

Instructor Profile:

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. 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.

Betty’s training experience includes over 25 years of training on all areas 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. Betty 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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