Anticipation and Expectations of a Medical OEM Design Control Audit 2014 is a webinar that covers topics such as:
- Dealing with the FDA and other authorizing bodies
- Champion/Multi-functional team approach/responsibility
- Design input/output
- Phase by phase design process check list
- Design changes
- Design verification/validation
- Design History File (DHF)
- Design review
- Gap analysis – data gathering for the design history files
- Due-diligence
- Design changes
- Risk assessment
- Planning to be prepared
Anticipation and Expectations of a Medical OEM Design Control Audit 2014 is intended for attendees from medical device and regulated companies:
- R&D and product development
- End-users responsible for design control and technical files
- Operations and plant management
- Process engineers and managers
- Remediation teams
- Validation engineers
- QC and Corporate Auditors
- QA, Regulatory Affairs
- Consultants
- All team members who contribute to design history files, clinical, verifications/validations, risk management or technical files
- Supplier management
- Project managers
- All Contract Manufacturers working in the medical industry
- Product transfer engineers
