Combination Product Compliance

  • 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  • Final Rule and Draft Guidance on Combination Product Good Manufacturing Practices; impact on pharmaceutical and medical device companies, contract manufacturers and constituent part and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.
  • Combination product breaking news and hot topics.