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Effective and Efficient Internal and Supplier Quality System Auditing for Medical Devices – GlobalCompliancePanel
November 10, 2016 - November 11, 2016$1,295
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.
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