Effective and Efficient Internal and Supplier Quality System Auditing for Medical Devices 2015 is a course that covers topics such as:
- How 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
- 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
- The difference between internal and external audits
- How to manage an internal audit system
- How using a risk -based process can make your audits more efficient and effective
- How the internal auditing system can add value to your quality system and your company
- What makes a good internal audit
- How an effective audit system can be an integral part of continuously improving your quality system and your company
- And have a chance to practice how to write effective audit non-conformances
- And have a chance to practice the skills required for an internal or supplier auditor
- What the FDA must see to verify that you are conducting your internal audits as required
Effective and Efficient Internal and Supplier Quality System Auditing for Medical Devices 2015 brings together attendees involved or interested in performing or managing audits of medical device quality management systems, including:
- Quality professionals
- Senior quality managers
- Internal or supplier auditors
- Regulatory professionals
- Audit managers
- New internal or supplier auditors
