Internal Auditing Essentials for Medical Device Manufacturers to comply with FDA QSR and ISO13485

Instructor: Susan C Reilly
Product ID: 700135
Training Level: Intermediate
  • Duration: 60 Min

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Mar-2007

Training CD / USB Drive

One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-362-2367


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The principles and practices needed to effectively develop, implement, and perform internal quality management system audits that comply with the requirements of the FDA QS Regulation and ISO 13485.


This medical Device training will provide the principles and practices needed to effectively develop, implement, and perform internal quality management system audits that comply with the requirements of the FDA QS Regulation and ISO 13485.

The operation of an efficient and effective audit program is fundamental to ensuring quality within your company. Participants will gain an understanding of QSR/ISO requirements and the skills necessary for effective internal auditing.

Areas Covered in the seminar:

  • Essentials of an internal quality audit program
  • How to implement an effective and efficient program
  • Audit phases
  • How to create an audit plan
  • Conducting the audit, including questioning techniques and communications
  • How to avoid common mistakes during audits
  • Corrective action for internal audits
  • How to select and train auditors

Who Will Benefit:

  • New or existing internal auditors
  • Management responsible for scheduling and overseeing internal audit programs
  • Potential auditees and having to deal with auditors and corrective action
  • Management Representatives
  • Quality Managers
  • Compliance Managers
  • Regulatory Professionals

Instructor Profile:

Susan C. Reilly, has over 20 years of quality system, quality engineering, and regulatory compliance experience in the medical device area. Her company provides practical and cost-effective quality and regulatory consulting services to ensure conformance with FDA regulations, EU requirements, Canadian requirements, and ISO Standards.

Prior to becoming an independent consultant in 1999, she was Director, Quality Systems, at Medical Device Consultants, Inc. (MDCI) and Manager, Quality Assurance at Deknatel Division, Pfizer Hospital Products Group, Inc. She was also a Quality Engineer at Burron Medical Inc.

Ms. Reilly has served as an expert witness on behalf of the Food and Drug Administration and was an active participant in the FDA/Medical Device Industry Initiative Task Force. She is a member of the Advisory Committee for the ASQ Certified Quality Auditor.

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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. ComplianceOnline 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 +1-888-717-2436 (Toll Free).

Product Reviews Write review

I was very appreciative to get a copy of the presentation in advance. It helped tremendously when trying to coordinate for everyone to view the material when we had participants from around the world attending....because network traffic was sometimes slow for viewing the presentation while it was given. Thank you for providing the presentation ahead of time.
- Anonymous

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