The principles and practices needed to effectively develop, implement, and perform internal quality management system audits that comply with the requirements of the FDA QS Regulation and ISO 13485. This medical Device training will provide the principles and practices needed to effectively develop, implement, and perform internal quality management system audits that comply with the requirements of the FDA QS Regulation and ISO 13485.
The operation of an efficient and effective audit program is fundamental to ensuring quality within your company. Participants will gain an understanding of QSR/ISO requirements and the skills necessary for effective internal auditing.
The operation of an efficient and effective audit program is fundamental to ensuring quality within your company. Participants will gain an understanding of QSR/ISO requirements and the skills necessary for effective internal auditing.
Areas Covered in the seminar:
- Essentials of an internal quality audit program
- How to implement an effective and efficient program
- Audit phases
- How to create an audit plan
- Conducting the audit, including questioning techniques and communications
- How to avoid common mistakes during audits
- Corrective action for internal audits
- How to select and train auditors
Who Will Benefit:
- New or existing internal auditors
- Management responsible for scheduling and overseeing internal audit programs
- Potential auditees and having to deal with auditors and corrective action
- Management Representatives
- Quality Managers
- Compliance Managers
- Regulatory Professionals
Course Provider
Susan C Reilly,
