For more information on accessibility, access procedures and deadlines, see our Training page.
Managing Product Safety – Responsibilities and Organisation – #16
790.00 € HT
Context
- European Directive 2001/95/EC and the amendments to Regulation 2023/988 of 10 May 2023 require manufacturers to organise product compliance.
- French law incorporates these obligations mainly in Article L421-3 of the Commercial Code.
- Product safety is a strategic issue for any company, as it has legal consequences for the company and criminal consequences for individuals.
- Product safety does not necessarily imply products that do not comply with specifications.
- Product safety concerns all industrial products, not just those involved in a safety function.
- These strategic issues require the strengthening of organisational processes.
Objectives
- Discover the regulatory context and understand product safety requirements.
- Understand the legal and criminal responsibilities involved in product safety and how to protect yourself.
- Understand why you may be held liable even if the product complies with specifications.
- Discover how to carry out preventive market surveillance as one of the entry points to product safety.
- Know how to respond in the event of proven risks related to product safety.
The scope of this training course: industrial products intended for the general public, excluding food products, pharmaceuticals and medical devices.
Recommanded for
- Members of the management team.
- Service/department managers.
- System auditors.
Specific operating conditions for remote sessions
- Have a PC equipped with a microphone, a webcam and, if possible, a headset for greater comfort. Note: wallpapers are available on Zoom or Teams to hide the background.
- Have a good Internet connection, which should be tested before the session.
- Settle down in a quiet, isolated place; set yourself to “unavailable” status on Teams; close your email access, and mute your phone, so as not to be disturbed during the session.
- Participants from the same organisation should not be grouped together in the same room, but each at their own desk.
- This Quiz must be taken with the webcam and microphone open. We may need to check that you are alone in the room.
- Please sign in 5 minutes before the start of the session.
Prerequisites
No prerequisites.
Pedagogy
The teaching method alternates between presentation sequences and role-playing exercises or group analyses, which are then shared.
Evaluation mode
- Knowledge test (multiple-choice questions) at the end of the training course.
Course materials
-
Participant’s file containing the presentations delivered during the training and the exercise materials.
To go further
Training :
Consulting services: EURO-SYMBIOSE can assist you in the concrete implementation in your company. Contact us to know more about it.
Session 1: The context
- The market
- The texts
Session 2 : The organisation of the company
- Services affected
Session 3: Building and managing product safety and regulatory compliance within the company
- Governance
- Implementation
- Evaluation
Session 4: Monitoring and responding to risks
- Internal and external monitoring
- Risk analysis with Safety Gate
Session 5: Conclusion
- Conclusion
- Knowledge test
About Instructor
Christelle GUYOT
Specialty: Project quality and audits.