Human Factors and Design Controls for Medical Devices and Combination Products 2015 covers topics such as:
- The new draft guidance on CGMP requirements for combination products
- Office of Combination Products Update
- The combination product development process
- Other recent and upcoming guidances and issues
- Companion diagnostics regulations, guidances, and challenges
- Clinical evidence development and coordination for combination products
- Industry assessment of FDA review of combination products
- FDA assessment of combination product submissions
- Quality by Design vs. Design Control
- Aligning pharmaceutical CGMP and device Quality System Regulations
- Human factors and combination products – paradigm matching
- Risk management and combination products
- Combination product inspections
- Reconciling drug and device postmarket requirements and processes
- Combination products in a global marketplace
Human Factors and Design Controls for Medical Devices and Combination Products 2015 brings together:
- Product stewards
- Drug, device, diagnostics, and biologics regulatory, quality, and clinical professionals involved with combination product development and oversight
- R&D and product testing professionals
- Business development executives involved in combination product strategic partnerships
- Combination product supply chain professionals