How to comply with and interpret FDA’s Final Rule: Post-marketing Safety Reporting for Combination Products.
What combination product regulations, guidance and standards do and do not exist, how to interpret, comply or conform to them and how to manage gaps in the regulatory framework.
Current FDA regulatory requirements and recommendations for combination products and industry best compliance practices.
Final Rule and Draft Guidance on Combination Product Good Manufacturing Practices; impact on pharmaceutical and medical device companies, contract manufacturers and constituent part and component part manufacturers; industry best compliance practices; FDA enforcement action.
How to implement design controls for legacy combination products and products in development.
Design verification, design validation and human factors usability studies in combination product development; current trends and industry best practices.
Reporting of post-approval design and manufacturing changes to combination product applications; presentation switches, bridging.
CMC requirements including stability studies, extractables and leachables, compendial requirements and standards.
Format and content of investigational exemption applications and marketing applications; eCTD, NDA/BLA format for device containing combination products.