- 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?
- Do you need to train new auditors for your medical device quality management systems or to audit your suppliers?
- Do you need to improve the training of your internal and supplier auditors so that they add value to these audits?
This course will address these key questions and also include:
- An easy to understand presentation of the auditing process as well as the requirements to audit under ISO 13485 and the FDA Quality System Regulation (cGMP).
- Discussions on auditing skills and hands-on auditing exercises.
- An overview of the requirements for Quality Management Systems (QMS) for both the FDA and ISO 13485.
- Best practices for creating and managing a value-added auditing process that will meet both company business needs and regulatory requirements.
- Review of all the quality management system requirements of FDA and ISO 13485.
- Steps to set up and manage an audit system that complies with these requirements and is risk-based so that your company makes the most efficient use of auditing resources for both internal and supplier audits.
- Interactive exercises to reinforce the fundamentals of conducting and documenting quality system audits.
This seminar has been designed for those who conduct internal and supplier audits and manage an audit process for company audits. Auditing principles taught in this seminar will be based on ISO 19011:2011 guidelines for auditing management systems.
Upon completing this course, participants will:
- 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 an internal auditing system that is compliant with 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:
This course is designed for people who perform 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 ISO 13485 and Quality Management Systems auditing will be covered.
- Senior quality managers
- Quality professionals
- Regulatory professionals
- Internal or supplier auditors
- New internal or supplier auditors
- Audit managers
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 more specific that you define a process that meets the requirements of the standard and are following your process. Both require that you define auditor training as required, but this sometimes just requires reading the company’s procedure, although most external auditors will look for more than this.