10:00 AM - 04:00 PM
DAY 1

Lecture 1:
- Complaint Handling and FDA Expectations

Lecture 2:
- Continuation Complaint Handling and FDA Expectations
- Medical Device Reporting Procedures (MDR) Regulations, Procedures, and Malfunctions

Lecture 3:
- Continuation of Medical Device Reporting Procedures (MDR) Regulations, Procedures, and Malfunctions
- MDR reporting by firm, agents Voluntary Malfunction Summary Reporting (VMSR) and eMDR Discussion

Lecture 4:
- Guidance Documents Update
- Being Recall Ready
- Questions and Recap

10:00 AM - 04:00 PM
DAY 2

Lecture 5:
- Recalls, Definition and Legal Authority Overview
- Corrective and Preventative Actions (CAPA)

Lecture 6:
- Health Hazard Evaluations HHE/HRA
- Elements of a Correction and Removal -- 806 Reporting

Lecture 7:
- Developing Effective Strategies / Communicating and Negotiating with FDA
- Notifications Letters and Press Releases
- Silent Recalls / Product Enhancements and Enforcement Actions

Lecture 8:
- Product Retrieval
- Status Reports
- Effectiveness Checks Follow-up Planning
- Terminating a Recall
- Wrap-up