"We provide knowledge and information about CGMP and Quality Systems to the Life Science industry"
Effective Management Controls
– for Medical Device Firms
This course provides you with the knowledge and confidence to interpret the ISO 13485:2016 and US Food & Drug Administration’s Management Responsibility requirements in the Quality System Regulation for your company’s operations.
In one fast-paced day, you will learn the key requirements of executive leadership for establishing and monitoring the Quality Management System in a risk-based paradigm for medical device or combination product companies.
- Management Responsibility, including Management Review and personnel
- A subsystem model for evaluating Quality Management System effectiveness
- Key quality indicators in the QMS
- Corrective and Preventive Action from an executive perspective
- Internal quality audit from an executive perspective
- Using risk in the QMS infrastructure
- Risk-based decisions – where they are appropriate
- Examples of implementing a risk-based management model
Note: This course is presented electronically. Each attendee must bring their own laptop to the course venue, Adobe PDF Reader is essential to fully participate in the course.
- Review and discuss the Management Responsibility requirements.
- Highlight key data in the Quality Management System that support Management Review and executive decision-making.
- Discuss Corrective and Preventive Action and internal quality audit as key executive management support tools.
- Discuss context of risk-based decision making and review opportunities to adopt a risk-based approach throughout the QMS.
Who should attend:
Intended for executive management of medical device or combination product companies, this fast-paced course is ideally suited to staff with responsibility for evaluating effectiveness of a Quality Management System. It is also intended for Management Representatives, and key staff responsible for Internal Audit.
When attending a Key2Compliance® course, you get access to Gate2GMP®, our document library and search tool.
At Gate2GMP® each course has its own page where you can download course materials, receive up to date information and communicate in the course forum.
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Medical Device industry
US and EU
Ms. Tammy M. Pelnik
Date, location and venue:
This course is only offered in-house.
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