This webinar will provide participants with key knowledge of medical device design controls by analyzing FDA 483 observations and learning what the agency is looking for with respect to each design control element.
For those that need a primer on where to focus their efforts, the best way to learn about design controls is from the mistakes that other companies have made and been cited FDA 483 observations for, so that these same mistakes can avoided. Breaking down FDA 483 observations yields a trove of information as to what is important to FDA that medical device manufacturers are not doing correctly.
Why Should You Attend:
Meeting design control requirements is essential to the success of any medical device company.For those that need a primer on where to focus their efforts, the best way to learn about design controls is from the mistakes that other companies have made and been cited FDA 483 observations for, so that these same mistakes can avoided. Breaking down FDA 483 observations yields a trove of information as to what is important to FDA that medical device manufacturers are not doing correctly.
Areas Covered in the Webinar:
- Design and Development Planning
- Design Inputs
- Design Output
- Design Reviews
- Design Verification
- Design Validation
- Design Transfer
- Risk Management
Who Will Benefit:
The following professionals from medical device start-ups and small to medium size device companies will benefit from this training:- Quality Assurance Engineers
- Developers
- Systems Engineers
- Quality Auditors
- Engineering Managers
- Documentation specialists
- Manufacturing Engineers
Course Provider
Mercedes Massana,
