2-day In-person Seminar

Effective and Efficient Internal and Supplier Quality System Auditing for Medical Devices


November 10th & 11th, 2016

Time: 9:00 AM to 6:00 PM

Jersey City, NJ

Venue: Courtyard Jersey City Newport


Director : Betty Lane
  Price: $1,495.00
(Seminar Fee for One Delegate)

  Register for 5 attendees   Price: $4,485.00
      $7,475.00 You Save: $2,990.00 (40%)*

**Please note the registration will be closed 2 days (48 Hours) prior to the date of the seminar.

Course "Effective and Efficient Internal and Supplier Quality System Auditing for Medical Devices" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

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. This course is for those who will do internal or supplier audits, manage an audit process for these or other company audits. This course will provide you with an easy to understand presentation on the auditing process as well as the requirements you will need to audit under ISO 13485 and the FDA Quality System Regulation (cGMP)

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 most concerned that you define a process that meets the requirements of the standard and are following your process. Both require that you define Auditor training is required, but this sometimes just requires reading the company's procedure, although most external auditors will look for more than this.

Do you need to train new auditors for yours medical device quality management system or to audit your suppliers? Or do you need to improve the training of your internal and supplier auditors so that they add value to these audits? If you need to do either of these, this seminar will provide this training. In addition to auditing skills and hands-on auditing exercises, this seminar will provide an overview of the requirements for Quality Management Systems (QMS) for both the FDA and ISO 13485, because auditors need to understand the requirements for the audits they conduct. This seminar will also cover the best practices for creating and managing a value-added auditing process that will meet both company business needs and regulatory requirements

In this seminar you will review all the quality management system requirements of FDA and ISO 13485 and then learn how to set up and manage an audit system that complies with these requirements, yet is risk-based so that your company makes the most efficient use of auditing resources for both internal and supplier audits. The seminar will include interactive exercises to reinforce the fundamentals of conducting and documenting quality system audits. Auditing principles taught in this seminar will be based on ISO 19011:2011 Guidelines for auditing management systems.


Why should you attend:

Internal and supplier audits are effective and efficient ways for your company to stay in compliance with ISO 13485 and or FDA Quality System Regulation requirements. They help you spot problems or potential problems before they become large issues and before they are found by external auditors. Therefore, it is of great benefit to companies to make sure their internal and supplier audits are trained in applicable standards, regulations, and the auditing process. It is also important that you establish and maintain an audit program that covers all requirements, both external and internal. Effective internal and supplier audits make good business sense.

This course is designed for people who preform 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 ISO13485 and Quality Management Systems auditing will be covered.

This course will be particularly helpful to the following

  • Senior quality managers who need to establish or manage an audit program
  • Quality professionals who need to know how to conduct effective internal or supplier audits
  • Regulatory professionals responsible for compliance
  • Internal or supplier auditors who need a better understanding of the auditing processor medical device quality management system requirements
  • New internal or supplier auditors
  • Audit Managers who need to update or streamline your internal auditing process
  • All Managers who need to establish an internal or supplier audit program

Areas Covered in the Session:

  • 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 and internal auditing system that is compliant to 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:

  • Quality Managers
  • Quality Engineers
  • Audit Managers
  • Supplier Engineers
  • Internal quality auditors
  • Supplier auditors
  • Quality associates
  • Quality Specialists
  • Regulatory Compliance Managers

Day 1 Schedule


Requirements of ISO 13485


Lecture 1:

Course Overview


Lecture 2:

Introductions - interview exercise


Lecture 3:

Overview of ISO 13485 and FDA Quality System Regulation (cGMP)


Lecture 4:

General Quality system requirements for Medical Devices


Lecture 5:

Document and Records Control


Lecture 6:

Management's Responsibilities including Management Review


Lecture 7:

Provision of Resources including human resources, training, facilities and work environment


Lecture 8:

Provision of Products and Services: How do you provide products and services to your customers


Lecture 9:

Exercise on Provision of Product and Services - what issues has you company had


Lecture 10:

Monitoring, Measurement and Improvement: How to 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)


Lecture 11:

Exercise on application of requirements


Lecture 12:

Q&A

Day 2 Schedule


Lecture 1:

The purpose of auditing


Lecture 2:

The difference between internal and external audits


Lecture 3:

Audit Planning

  • The Audit Manager
  • How to create an audit schedule
  • Tracking audit performance

Lecture 4:

The audit process and our procedures

  • Audit Preparation & Planning
  • Check lists
  • Audit Notice
  • Opening Meeting
  • The audit
  • Specific items to check in various areas
  • Comments and nonconformities
  • Audit Report

Lecture 5:

How to say things properly on audit paperwork


Lecture 6:

Exercise on writing nonconformities

  • Corrective Actions
  • Closing the audit

Lecture 7:

Practice Audits


Lecture 8:

What the FDA can ask for concerning internal and supplier audits


Lecture 9:

Q&A


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Group participations
Get fabulous discounts by participating in groups of two or more.
No Attendees Discount
1 2 Attendees 10% off
2 3 to 6 Attendees 20% off
3 7 to 10 Attendees 25% off
4 10+ Attendees 30% off

To avail the above group discounts, all the participants should register by making a single payment

Call our representative TODAY on 1800 447 9407 to have your seats confirmed!

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. Her work enables companies to manage their business in compliance with FDA and ISO 13485 requirements, as well for quality system requirements for other geographic area such as Europe and Canada. Her background in digital systems engineering enables her to facilitate quality system processes for 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 aspects of ISO 13485, the ISO standard for Medical Device - Quality Management Systems - System Requirements for regulatory purposes, and FDA Quality System Regulation - Medical Devices; Good Manufacturing Practice (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 device and biotechnology 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 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 (RPI), and an MBA from Northeastern University.

Location: Jersey City, NJ Hotel: Courtyard Jersey City Newport   540 Washington Boulevard Jersey City New Jersey 07310 USA

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