**Please note the registration will be closed 2 days (48 Hours) prior to the date of the seminar.
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.
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
The purpose of auditing
The difference between internal and external audits
The audit process and our procedures
How to say things properly on audit paperwork
Exercise on writing nonconformities
What the FDA can ask for concerning internal and supplier audits
|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 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.