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1st Edition  Conference

Managing Your Complaints and Obstacles in Post-Market Requirements -- Results from Top Medical Device Observations During an Inspection


"Evaluating Risk and Health Hazard Evaluation"
Managing your Complaints and Obstacles in Post-Market Requirements -- Results from Top Medical Device Observations During an Inspection is a platform to discover how to overcome one of the biggest obstacles device manufacturers face, how the FDA expects you to develop and implement proper handling of complaints reportable or non-reportable, product complaint handling and documentation, and how and when to file Medical Device Reports (MDR), effective and appropriate communication with the appropriate regulatory agencies in the event of a recall.Post-Market activities, Complaint Handling, MDRs, and Recalls are expensive, time consuming, and often lead to more serious financial consequences. Over 80% of FDA Inspection target observations for lack of compliance in these areas.


Highlights

  • Understand how to comply with complicated Compliant Handling, MDR and Recall requirements
  • Company preparation in the event of a Recall, recall strategy, notification letter and communicating
  • Assist with the creation and maintenance of effective procedures for handling complaints
  • Discussion of FDA’s New Guidance’s on Risk and how it interacts with Recalls
  • Minimize your risk of regulatory enforcement actions,Walk-through of case examples

Timings

8:30 AM - 5:00 PM (Sep 12) (General)
8:30 AM - 4:00 PM (Sep 13) (General)

Entry Fees

Paid Ticket Starts from 1699 USD View Details

Participants

20
Delegates

5 Exhibitors Estimated Count

Category & Type

Conference
Medical & Pharma
Education & Training

Editions

12-13 Sep 2019 1st Edition


Frequency Bi-annual
Next edition likely in Mar 2020 Interested

Official Links

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Organizer

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ComplianceOnline USA

Top Rated 351 events listed

User Community [ Users who have shown interest for this Event ]

Dallas L. Thomas, RAC, MHA, MPA

Dallas L. Thomas, RAC, MHA, MPA

Regulatory Affairs and Quality Auditing Consultant for Medical Device at Thomas Regulatory Resolutions, Inc.

Orlando, United States
ousama bakir

ousama bakir

anesthesia technician at skiekh khalida specialty hospital

Ras Al-Khaimah, United Arab Emirates

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1699 USDAttendee Seminar One Registration
32.718334 -117.157870

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