Streamlining your QMS and Audit System for Remote Audits

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.

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Last Recorded Date: Oct-2020

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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 Betty Lane

Founder and President, 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 for both FDA and ISO 13485 compliance band business when they became FDA and industry requirements. Her are areas of expertise include training, auditing, supplier management, design controls, software validation and general safety.

Betty’s training experience includes over 25 years of training on all areas ISO 13485 and FDA cGMP, in companies where she worked as manager or director, and for AAMI, ASQ biomedical division, and ASQ sections. She has taught courses in medical quality and regulatory affairs as an Adjunct 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 RAPS, 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.

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. FDATrainingAlert would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email call +1-888-771-6965 (Toll Free).

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