DUBLIN--(BUSINESS WIRE)--Research and Markets (http://www.researchandmarkets.com/research/f44ncg/effective) has announced the addition of the "Effective Complaint Handling, Medical Device Reporting and Recalls and Avoiding Costly Errors: One and a Half-day In-Person Seminar" conference to their offering.
This interactive one and a half day course lead by FDA's recently retired CDRH Recall Branch Chief Rita Hoffman who has more than 36 years' experience in FDA compliance issues will provide the participants tools to minimize risk of regulatory enforcement actions.
During the seminar, she will explain proper handling of complaints reportable or non-reportable, product complaint handling and documentation, how and when to file Medical Device Reports (MDR), effective and appropriate communication with the appropriate regulatory agencies in the event of a recall.
Key Topics Covered:
Conference Day One (8:30 AM - 4:30 PM)
Registration Process: 8:30 AM - 9:00 AM
Session Start: 9:00 AM
Introduction to class (20 min)
Complaint Handling and FDA Expectations (70 min)
Medical Device Reporting Procedures (MDR) (60 min)
MDR FDA Perspective (30 min)
User Error Malfunction
Recalls: Definitions and Legal Authority (45 min)
Being Recall Ready -Proactive Steps to Avoid Crisis (45 min)
Evaluating Risk and Health Hazard Evaluation (HHE) (60 min)
Conference Day Two (8:30 AM - 12:30 PM)
Developing effective Strategies and Communicating with FDA (80 min)
Silent Recalls vs. Product Enhancements (20 min)
Product Retrieval Issues, Effectiveness Checks and Status Reports (50 min)
Recalls and Other Field Actions (30 min)
Termination of a Recall (15 min)
Mock Recall and Wrap-up (35 min)
For more information visit http://www.researchandmarkets.com/research/f44ncg/effective
