ISO 13485 Audit Preparation 

We offer 5 Medical Device Quality System Training courses:

• Executive Certificate
• Engineer/Manager Certificate
• Operations Certificate
• ISO 13485 Internal Audit Certificate
• Cleanroom Processes

Courses will cover: current FDA positions, how to prepare for a visit from regulators, and a general roadmap for improving the organization’s quality management system to meet FDA regulations.

For more information on the ISO 13485 certificate please call Continuing and Professional Education  at 330-972-7577 or email us at learn@uakron.edu 

Who Should Attend:

• Top management

Course Outline:

• Introduction: the current regulatory environment for the medical device industry; what it means for the organization
• Requirements of the FDA’s QSR (in the context of ISO 13485); a general discussion of each section, with special emphasis on key / troublesome requirements
• What is a visit by FDA auditors like? The logistics and mechanics, what auditors are looking for, how the organization can prepare
• Most frequent reasons companies receive observations / warning letters from the FDA
• The way forward: how to strengthen the current quality system and make it more robust; planned training, new initiatives
• Developing Protocols for FDA visits
• How does this apply to an employee for a manufacturing medical device company

Who Should Attend:

• Management and engineering staff

Course Outline:

• Introduction: the current regulatory environment for the medical device industry; what it means for the organization
• Requirements of the FDA’s QSR; a detailed discussion of each section, with special emphasis on key / troublesome requirements, and how each section relates to the requirements of ISO 13485 quality management system standard.
• What is a visit by FDA auditors like? The logistics and mechanics, what auditors are looking for, how the organization can prepare
• Most frequent reasons companies receive observations / warning letters from the FDA
• The way forward: how to strengthen the current quality system and make it more robust; planned training, new initiatives
• Developing OEM to Contract Manufacturing ISO statement of work
• How does this apply to an employee for a manufacturing medical device company

Who Should Attend:

• Operators involved in the manufacture and/or handling of medical devices

Course Outline:

• Introduction: the current regulatory environment for the medical device industry; what it means for the organization.
• Most frequent reasons companies receive observations / warning letters from the FDA
• The importance of following procedures and adhering to the requirements of the FDA’s QSR and ISO 13485.
• Key items for operators: follow SOPs, identification and traceability of products and returned products, creating device records, record retention
• How does this apply to an employee for a manufacturing medical device company

The hands-on activities and simulations in this 12-hour program include auditing terms and definitions, the process model, the process audit versus the system audit, audit skills and techniques, planning, performing and reporting the audit, and the corrective action process.

This four-hour course introduces the strategies and tactics commonly employed to maintain cleanroom environments.  The session reinforces the link between standard cleanroom strategies and theory and the company’s internal procedures. Email learn@uakron.edu for more information.