Upcoming Program Topics

Below are several planned topics for the upcoming year – please note that dates and details are subject to change. Subscribe to our emails and event calendar for the most current program information and registration details.

  • Ask Me Anything: Human Factors/Usability for Medical Device Submission  
  • From Concept to Commercialization: Roundtable for Medical Device and Biopharma Startups
  • LDTs and the FDA Final Ruling
  • De Novo Submission, from Strategy to Approval
  • Essentials of Packaging Validation for Medical Device Professionals
  • FDA QMSR Compliance
  • Managing Post-Approval Drug Changes and Submissions
  • Managing Global Regulatory Assessments and Submissions for Modified Devices – Best Practice, Points to Consider, and Pitfalls to Avoid
  • Complaint Handling in the Social Media Era
  • IND/NDA Regulatory Submission Workshop
  • Essentials of Sterilization Validation for Medical Device Professionals
  • Optimize Your Process for Streamlined and Sustainable Risk Management Throughout Product Lifecycle
  • Managing Post Market Surveillance for Global Markets