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.

July
  • Ask Me Anything: Human Factors/Usability for Medical Device Submission  
  • From Concept to Commercialization: Roundtable for Medical Device and Biopharma Startups

August

  • FDA QMSR Compliance
  • Global Cosmetic Labeling & Registration Strategy – with a Focus on US, EU, and China
September
  • De Novo Submission, from Strategy to Approval
  • Essentials of Packaging Validation for Medical Device Professionals
October
  • Managing Post-Approval Drug Changes and Submissions
  • Managing Global Regulatory Assessments and Submissions for Modified Medical Devices – Best Practice, Points to Consider, and Pitfalls to Avoid
November
  • Complaint Handling in the Social Media Era
  • Food Importation & Labeling Requirements, Common Custom Clearance Issues, and Pitfalls to Avoid
  • Essentials of Sterilization Validation for Medical Device Professionals
December
  • Optimize Your Process for Streamlined and Sustainable Risk Management Throughout Product Lifecycle
  • LDTs and the FDA Proposed Ruling