Combination Products: Human Factors-Usability, Quality Systems and Design Controls for Drug Delivery Devices

  • 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.