Current Regulations under FDA and HIPAA 2015

Topics

• HIPAA and MedWatch
• U.S. FDA and HIPAA
• HIPAA and Mammography Quality Standards Act (MQSA) and similar: Inspections, Outcomes Audits and Reporting
• HIPAA and IRB’s
• HIPAA and the new UDI / GUDID
• HIPAA and Electronic Records / Submissions

Who should Attend

• Clinicals personnel Medical personnel and other healthcare professionals
• Senior management in Biologics
• Consultants