Combination Products: Establishing and Utilizing an Integrated Approach to Developing Drug/Biologic Containing Medical Devices and Delivery Systems

  • Final rule and guidance on combination product good manufacturing practice; Design Control and drug cGMP requirements impacting pharmaceutical and medical device manufacturers, contract manufacturers and combination product constituent part and component part manufacturers.
  • Integration of device Design Control and drug cGMP requirements into existing pharmaceutical and medical device development practices and quality systems
  • How to apply risk assessment and management processes in support of compliance with the new combination product post-marketing safety reporting rule.
  • Key governance and management systems practices intended to effectively integrate product development and a design review process.
  • How pharmaceutical and medical device voice of the customer practices can be integrated into user requirement/design inputs and drive the development process.
  • Drug and device characteristics important in design verification planning to provide objective evidence that design outputs satisfy design inputs.
  • Utilizing human factors/usability engineering in device, drug and combination product design development.
  • Use of drug and device clinical and human factors studies and device benchtop testing to satisfy design validation requirements.
  • How to integrate project management and design and development planning to effectively define drug and device development activities, needed resources, interfaces, responsibilities, and activities.
  • Application of design transfer practices to ensure device and pharmaceutical requirements are effectively integrated into existing pharmaceutical manufacturing process transfer practices.
  • The use and benefits of a Device Master Record in satisfying design output requirements.
  • How to manage design changes and modifying existing change control systems to comply with design control requirements.
  • Implementation of effective pre- and post-market Design History File practices to integrate drug, device and the combination product design evolution.
  • Use of a Quality and Compliance Plan to identify procedures and resources for combination product development and plan implementation of quality system elements into medical device or pharmaceutical development organizations.
  • Compliance and Enforcement – Current FDA’s approach to evaluating the Design Controls process; how to prepare for a combination product design control inspection.