Conformance of Design History Files for Mature Medical Products 2013 is a webinar that covers topics such as:
- Set procedures and template to complete remediation for design history file of old products to meet current standards
- Multi-functional team approach/responsibility
- Gathering of data to build the design history files
- Gap analysis
- Risk assessment for prioritizing remediation
- Risk procedure
- Validations
- Traceability matrix
- Check list
- Dealing with the fda
Conformance of Design History Files for Mature Medical Products 2013 brings together:
- R&D and product development engineers and managers
- End-users responsible for design control and technical files that need to be updated to the current standards
- Remediation teams
- Validation Engineers
- Consultants
- QA, Regulatory Affairs and team members who contribute to design history or technical files
- Corporate auditors
