Seminar Topics

Unites States Medical Devices

• FDA Overview
1. Device Risk Classification & the Approval Process
2. Pre-market notification, 510(k)
3. Pre-market Approval (PMA)
4. Interacting with the FDA - From Regulations to Reality: A former FDA Reviewer's perspective
• Pre-Clinical Considerations for FDA Submissions
  1. Developing a successful strategy
  2. Standards and guidance
  3. Technical Report Writing
• Combination Products
1. Regulatory Challenges
2. Examples of drugs/biologics device combinations
3. Case study: Drug Eluting Stents
• Quality Systems Regulations
1. Purpose of Quality System
2. The Quality System Regulations (QSRs)
3. ISO 13485
4. Combination Products: QSRs and CGMPs
• Chemistry, Manufacturing and Controls (CMC)
1. Contents of the CMC Section
2. Case Studies
• FDA Inspections
  1. The QSIT Process
  2. Preparation for an Inspection
  3. What Happens During the Inspection
  4. After the Inspection