Safety assurance cases are required by the FDA as part of 510(k) submissions for new infusion pumps. Adelard offers a 2-day training course on the development of safety assurance cases, covering the fundamental concepts, regulatory requirements, methodologies and best practice in the industry.
Dates and Locations
The training course may be offered in-house (also in the US), or as a public course in London, UK. Please contact us for more information.
Who should attend?
The training course addresses quality assurance, regulatory affairs and engineering. We recommend that a combination of staff from these areas participate as these will all be providing input into the assurance case.
The aim of the course is to enable safety participants to:
- Understand fundamental assurance case theoretical and methodological concepts
- Apply these concepts towards meeting FDA requirements
- Understand the technical and project challenges associated with developing an assurance case (and an assurance case report)
- Address cyber-security within the safety assurance case
Duration: 2 days
Session 1: Introduction to assurance cases
The first session provides a general introduction to assurance cases, drawing upon experience from all safety-critical industries that have historically been using assurance cases (rail, aviation, nuclear energy, defence). The following issues are covered:
- What are assurance cases?
- What is the problem they are trying to address?
- What are the key concepts and terminology?
- What is the lifecycle of an assurance case?
- How are assurance cases used by the regulator?
Session 2: Assurance cases for infusion pumps
This session focusses on the requirements of the FDA for new infusion pumps. Here we will review the latest FDA guidance (2015) and explain and discuss how these apply to your project and device. The following issues are covered:
- What is required by the FDA?
- What are they key documents needed for the assurance case?
- How does ISO:14971 and overall risk management feed into the assurance case?
Session 3: Developing assurance cases using CAE
This session is a tutorial on the application of the CAE approach; a method for systematically developing the (graphical) assurance case argument structure. The following issues will be covered:
- Where do I start? Where do I stop?
- How big should the assurance case argument be?
- What types of arguments are available?
- How do I decide what argument to use for a specific claim?
Session 4: Best practice in assurance case development
In the beginning of the second day, this session provides an overview of a variety of practical issues that need to be considered from a project perspective. The following will be covered:
- Who are the stakeholders involved?
- How is size and complexity managed?
- How is evidence integration managed?
- What tools are available for assurance case development?
Session 5: Engineering challenges
This session focusses on a set of specific areas of engineering that are challenging and important to safety, and as such play a key role in the assurance case. The following will be covered:
- Risk management and engineering
- Human factors and usability
- Software development
Session 6: Half-day workshop
This final session is a practical workshop where the participants will be allowed to apply the concepts covered over the past 1.5 days in order to develop an assurance case structure that can be used as the basis for their actual assurance case.
Fees and Registration
Please contact us for further details.