Conformance of Design History Files for Mature Medical Devices 2015 is a webinar that covers topics such as:
- Set procedures and template to complete remediation for design history file of old devices to meet current standards
- Multi-functional team approach/responsibility
- Data gathering to build the design history files
- Gap analysis
- Risk assessment for prioritizing remediation
- Risk procedure
- Dealing with the FDA
- Validations
- Phase by phase check list
Conformance of Design History Files for Mature Medical Devices 2015 brings together:
- End-users responsible for design control and technical files that need to be updated to the current standards
- Senior management
- Process engineers and managers
- R&D and product development
- Validation engineers
- Operations and plant management
- Documentation teams
- Remediation teams
- QC and Corporate Auditors
- QA, Regulatory Affairs
- Consultants
- All team members who contribute to design history, clinical, validations or technical files
- All Contract Manufacturers working in the medical industry
