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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.

Learning Objectives:
Understand how to comply with complicated Compliant Handling, MDR and Recall requirements.
Firms MDR reporting and FDA's handling of reports.
Company preparation in the event of a Recall, recall strategy, notification letter and communicating with the FDA.
Minimize your risk of regulatory enforcement actions.

Who will Benefit:
This course will benefit anyone in the medical device industry that handles functions involving product complaints, recalls, medical device reporting.

Regulatory Affairs
Project Managers
Regulatory Professional
Risk Managers


Use coupon code NB5SQH8N and get 10% off on registration.

For Registration:

There may be many networking opportunities at the Post-Market Compliance for Medical Devices and Evolving Reporting Requirements: Complaint Handling, MDR/eMDR and Recalls including UDI update. Find out more in the event details below.

All information in Events In America is deemed to be accurate at the time we add it, and we take steps to verify all details and update our records when new information is provided, but as people, events and circumstances change, we caution users to independently confirm all information. and Events In America LLC make no guarantee of accuracy and assume no liability for inaccurate information.

Conference/Event Dates: 06/16/2016 - 06/17/2016
Conference/Event Hours: 8:30 AM - 12:00 PM
Classification: B2B
Primary Industry: Medical
Other Industries: Manufacturing, Medical
Estimated Attendance: 30
Cost to Attend: One Registration - $1699
Audience: Regulatory Affairs
Project Managers
Regulatory Professional
Risk Managers
Complaint Handling Teams
CAPA Teams
Venue: Double Tree San Diego Downtown
Venue Phone: (888) 717-2436
Venue Type: Indoor - Hotel
Show Owner:ComplianceOnline

Booth Size Booth Cost   Available Amenities
Call for information.   Electricity: n/a
  Water: n/a
  Generator: n/a
  Marketing Vehicles Allowed: Call
Other Booth Sizes Available: n/a

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