Conformance of Design History Files for Mature Medical Products 2013

Topics

• 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

Who should Attend

• 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