Navigating the Maze for Post-Market Compliance: Guidance on FDA Risk Benefit - One and a Half-day In-Person Seminar by Ex-FDA Official (Tampa, FL, United States - February 2-3, 2017) - Research and Markets

DUBLIN, Dec 14, 2016 /PRNewswire/ --

Research and Markets has announced the addition of the "Navigating the Maze for Post-Market Compliance - Complaint Handling, MDRs, Recalls and Proposed Guidance on FDA Risk Benefits: One and a Half-day In-Person Seminar by Ex-FDA Official" conference to their offering.

This interactive one and a half day course led by Ms. Rita Hoffman, Former FDA CDRH Recall Branch Chief, who has more than 36 years' experience with the FDA will provide the participants tools to minimize risk of regulatory enforcement actions.

During the seminar, Ms. Hoffman 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. She will also discuss how to conduct a correction and removal actions to avoid a recall crisis, including required recordkeeping, expectation from FDA and other regulatory agencies in the event of a recall and key factors in implementing and maintaining compliance with the regulations and real life experiences of FDA.

Agenda:

Day 01 (8:30 AM - 5:00 PM)

08.30 AM - 09.00 AM: Registration
09.00 AM: Session Start
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)

Day 02 (8:30 AM - 12:00 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)
Termination of a Recall (15 min)
Mock Recall and Wrap-up (35 min)

For more information about this conference visit http://www.researchandmarkets.com/research/x4hqqv/navigating_the

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