This 60 minute webinar on a Design Control Audit by the FDA and other bodies will provide an understanding of what a medical OEM should anticipate during an audit during a design control audit. All medical device companies that are in need of examining their design control process should be aware of what to expect.
The FDA and other authorizing bodies have become more stringent in their examination of medical OEM procedures, process, and data. Many medical industry companies have not completed all their testing and design reviews before commercializing products properly or brought their mature product lines up to current FDA standards and are not in total compliance. This webinar shows the process to be followed for developing a standard procedure to identify what is expected for design control.
For example, companies should be compliant to 21 CFR 820, ISO 13485:2003, ISO 14971:2007, etc. Design History Files and validations need to be up to date to meet current standards. The FDA and other authorizing bodies expect continuous improvement and risk management to be integrated into the company quality system. Old medical devices need to have a risk assessment for each product and updated validations for product and processes. It should describe the risk acceptance criteria as well as roles and responsibilities of each member on the team.
In this webinar, we will discuss practical steps you can follow to make sure your product design control and quality files are ready for an audit. It will also give the attendee guidelines on how to deal with the authorizing bodies.
- Champion/Multi-functional team approach/responsibility
- Dealing with the FDA and other authorizing bodies
- Phase by phase design process check list
- Design input/output
- Design verification/validation
- Design changes
- Design review
- Design History File (DHF)
- Due-diligence
- Gap analysis – data gathering for the design history files
- Risk assessment
- Design changes
- 483 warning letters
- Planning to be prepared
This webinar will provide valuable assistance and give a process to all medical device and regulated companies that need to prepare for an FDA or authorizing bodies audit in the future. The employees who will benefit include:
- OEM and CMO Quality Managers
- OEM and CMO Quality Engineers
- End-users responsible for design control and technical files
- R&D and product development
- Process engineers and managers
- Operations and plant management
- Validation engineers
- Remediation teams
- QA, Regulatory Affairs
- QC and Corporate Auditors
- All team members who contribute to design history files, clinical, verifications/validations, risk management or technical files
- Consultants
- Project managers
- Supplier management
- Product transfer engineers
- All Contract Manufacturers working in the medical industry
MD1596
