Susanne Manz, MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. She has a BS in Biomedical Engineering and an MBA from the University of NM. She earned her Black Belt and Master Black Belt certifications while at Johnson and Johnson. Susanne also holds Regulatory Affairs Certification (RAC) from RAPS and Certified Quality Auditor (CQA) certification from the American Society for Quality. Susanne has now established a consulting business with a mission to provide services to help medical device companies achieve world-class quality and compliance.

Course Description:

The objective of this Online Training & webinar on ISO 14971 Risk Management and Risk Management Process is to provide participants with an overview of risk management requirements per ISO 14971, Application of Risk Management to Medical Devices, and the procedural infrastructure required to integrate risk management throughout the product lifecycle.

Course Objective:

More medical device manufacturers are seeing the implementation ISO 14971 as a best practice within their business processes. ISO 14971 for the application of risk management helps manufacturers introduce safe medical devices into the market place.

Whether the implementation is procedural or deployed using enterprise risk management software, the ability to implement an effective ISO 14971 risk management processes depend upon using proven approaches that will facilitate application. Regardless of the level of automation deployed, the goal is to implement an ISO 14971 risk management process that is integrated, continuous, and responsive and applied in a manner to provide benefits throughout the product lifecycle.

From a compliance perspective, the risk management topic has become more present in FDA Warning Letters and 483’s. It is important to demonstrate due diligence in the application risk management and the deliverables needed to stand the challenge of an audit.

Course Outline:

Overview of ISO 14971
Relationship of Risk Management to the Quality System and Product Life cycle
Pr-requisites and Planning for Risk Management Process
Establishing a hazards and harms profile that includes severity and/or adverse health outcome
Risk Management Process Procedural Infrastructure
Example Risk Management Process Diagrams
Overview of Policies, Procedures, Work Instructions and Templates
Establishing Severity of Harm Scale, Probability of Harm Scale, Risk Acceptability Criteria
Example Warning Letter Excerpts Associated with Risk Management
Example 483’s Excerpts Associated with Risk Management

Target Audience:

Quality and regulatory professionals whom want to better understand the application of ISO 14971 throughout the product lifecycle and how to improve the application of risk management within their facility.

Learning Objectives:

Upon completion of this session, attendees will learn how ISO 14971 may be applied throughout the product lifecycle, the overall relationship of risk management to the quality system, and the type of policies, procedures and associated work instructions that may be deployed for an effective risk management process.

Regards,

Joshua

Training Manager

Email: [email protected]

Call us at : 1-732-7225220

Website: compliance.world

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