Combination Products: A Structured Approach to Complying with Post-marketing Safety Reporting and Good Manufacturing Practices

  • How to comply with FDA’s Final Rule on Post-marketing Safety Reporting for Combination Products and its impact on pharmaceutical and medical device companies, and constituent part manufacturers; what to consider when designing a post-marketing safety reporting system
  • How to comply with FDA’s Final Rule and Guidance on Combination Product Good Manufacturing Practice and its impact on pharmaceutical and medical device companies, contract manufacturers and constituent part and component part manufacturers; industry best compliance practices and FDA enforcement
  • Required actions resulting from the interplay between safety reporting, good manufacturing practices and corrective action requirements
  • How to improve current complaint management system which may be inadequate for complaint device failure/malfunction investigations
  • Integration of device design controls and drug cGMP requirements into existing pharmaceutical and medical device development practices and quality systems
  • How to utilize design controls, risk management and human factors engineering in medical device and pharmaceutical environments, to legacy combination products and combination products currently in development to improve design and comply with regulations