Course: HLTH201
Section: 1F08
Date: Not Yet Scheduled
Location: Fogelman College of Business, Education Suite – Room 385
Program Fees: $1295 per individual; 10% discount for 3 or more registrations from the same organization
Enroll online: Not Yet Scheduled

This 2-day course is designed to give you the most updated information on the FDA requirements for QSR and product safety. Case studies, workshops and interactive discussions are used throughout the sessions to demonstrate how these new regulations affect you and your business. Benefits include:

• Understand the FDA’s regulatory history affecting medical devices manufactured for use in the United States
• Learn about the FDA’s objective to harmonize US medical device regulations with the international community
• Review risk management and guidance documents
• Learn inspectional strategies used by the FDA

Topics Covered in the Program Include:

• Explanation and review of the QSR
• How TC 210 affects change within the medical device industry
• Harmonization with international regulations
• How to make the transition into a tiered quality system
• Relationship between ISO 9001, ISO 13485 and the European Union’s CE Marking requirements
• How the guidance documents relate to the requirements
• Timelines for compliance
• Overview of Design Control
• FDA’s expectations of Product Safety

Who Should Attend?

Faculty: Ron Belmont, Vice President, Healthcare Practice, SAI Global

Ron is a recognized expert in the regulatory arena with over 30 years of domestic and international experience with both regulated and unregulated industries. His vast experience, expertise and knowledge enable him to provide practical guidance for each client in areas such as manufacturing processes, quality systems and business performance.

Ron has led SAI Global's regulatory program (medical device, pharmaceutical, biotech) for over 16 years. He has utilized his engineering education and in depth experience in R&D, product safety, product management and regulatory affairs in the development and implementation of effective quality systems that not only comply with domestic/international regulatory requirements and standards, but enhance overall business operations and improve the bottom line.

Ron has worked with companies ranging from small, private organizations to Fortune 100 firms within industries including medical device, biotech, pharmaceutical and contract manufacturing as well as with government agencies (both US and international). He has worked with a number of companies in Europe, where he was responsible for implementing quality systems that met the requirements of ISO 9001, ISO 13485, FDA's cGMPs/QSR, and other specialized industry standards.