Advanced seminar and workshop on risk management – Module 2
Description
The advanced seminar with workshop expands on Module 1 and can only be booked together with Module 1. It is designed to explain the use of risk management tools using a range of practice-based examples. In this process, customer requirements are specified and systemic requirements regarding the design and the manufacturing process are determined. It demonstrates the links to the specifications/requirements specification for the development process (design input) and presents tools for tracking the measures until they are completed (traceability matrix in combination with phase-controlled design reviews; design input versus design output).
Contact Person
Goals
This seminar presents the processes and tools involved in risk management, which are used during the different phases of the product life cycle to safely determine requirements, assess risks and minimise risks. It explains the potential methods that can be used for risk analysis and how they are implemented (FMEA, FTA) using examples. Additional examples are also provided in order to demonstrate how requirements can be examined clearly in the design review phase (traceability matrix).
Seminar content
- Implementing product management specifications and the content of the marketing plan (customer requirements)
- Determining design requirements (specifications)
- Structured creation of requirements specifications
- Performing risk analyses regarding the design and process requirements (FMEAs/FTAs)
- Implementing the concept of integrated safety
- Minimum content of design specifications for medical devices
- Transferring the design requirements into design review structures (traceability matrix)
- How considerations relating to ergonomics and fitness for purpose affect the design process
- Creating the testing and verification/validation plan with respect to the product design
Target group / seminar duration and certificate
This seminar can only be booked together with Module 1 and is suitable for employees who deal with risk management in the product development, manufacturing and post-market surveillance stages, as well as staff who are responsible for regulatory purposes, and auditors.
The content is presented over the course of a one-day seminar. The participants receive a certificate of attendance and, on request, materials for participants in physical or digital form.
Seminar inquiry© Schrack & Partner. All rights reserved.