Topics
- How to identify and assess the regulatory requirements
- The recent changes in the 510(k) program and guidance documents relating to both 510(k)s and PMAs
- How to increase a 510(k) and PMA submission quality
- How to meet the regulatory requirements in a systematic, integrative manner
- How to format succinct and comprehensive 510(k) and PMA submissions
Who should Attend
Anyone in the FDA-regulated industry including, medical device, drugs, biologics, in vitro diagnostic devices or any combination products :
- Clinical affairs (associates, specialists, coordinators, managers, directors and VPs)
- Regulatory affairs (associates, specialists, managers, and directors)
- Research and development (associates, scientists, managers, directors and VPs)
- Quality assurance, quality control, and quality systems (associates, specialists, engineers, managers, directors and VPs)
- Marketing (associates, specialists, managers, directors and VPs)
- Product and development (associates, scientists, managers, directors and VPs)
- Contract manufacturing organization (associates, scientists, managers, directors and VPs)
- Site managers, and consultants
- Senior and executive management (VPs, SVPs, Presidents and CEOs)
- Contract research organization (associates, scientists, managers, directors and VPs)
- Contractors and subcontractors
