Building, optimizing and applying human factors and usability engineering processes
Understanding human factors and usability expectations of three different FDA centers.
Establishing reasonable expectations with reviewers so that review meetings and submissions have successful outcomes.
Utilizing human factors and usability studies to identify potential use errors and their mitigations when developing a new device or modifying an existing device.
Writing a Human Factors Validation protocol for human factors and usability engineering. When it’s necessary to submit it for review prior to execution.
The most significant human factors and usability deficiencies cited FDA over the past decade.
The most common reasons why companies and regulators differ over human factors/usability issues.
Applying human factors and usability engineering principles to legacy products.
Using human factors/usability engineering in evaluating potential device suppliers.
The key human factors/usability questions to ask device vendors.
How to comply with current quality systems regulations, directives, guidance and standards for device-containing combination products and their applicability to pharmaceutical and medical device developers, contract manufacturers and constituent part and component part manufacturers.
Interpretation of current quality system guidance, industry best compliance practices, recent inspectional experience and FDA enforcement action for device containing combination products.
How to implement and utilize design controls, including design verification and validation testing, during development of device containing combination products.
What to do about a Design History File for a legacy product.
Including compliance information in marketing applications.