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.