Internal Auditing Essentials for Medical Device Manufacturers to comply with FDA QSR and ISO13485

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.

• 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

• 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

Instructor Profile
Susan C. Reilly, has over 20 years of quality system, quality engineering, and regulatory compliance experience in the medical device area. Her company provides practical and cost-effective quality and regulatory consulting services to ensure conformance with FDA regulations, EU requirements, Canadian requirements, and ISO Standards.

Prior to becoming an independent consultant in 1999, she was Director, Quality Systems, at Medical Device Consultants, Inc. (MDCI) and Manager, Quality Assurance at Deknatel Division, Pfizer Hospital Products Group, Inc. She was also a Quality Engineer at Burron Medical Inc.

Ms. Reilly has served as an expert witness on behalf of the Food and Drug Administration and was an active participant in the FDA/Medical Device Industry Initiative Task Force. She is a member of the Advisory Committee for the ASQ Certified Quality Auditor.