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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.
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.
Use coupon code NB5SQH8N and get 10% off on 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.
|Conference/Event Dates:||06/16/2016 - 06/17/2016|
|Conference/Event Hours:||8:30 AM - 12:00 PM|
|Other Industries:||Manufacturing, Medical|
|Cost to Attend:||One Registration - $1699|
Complaint Handling Teams
|Venue:||Double Tree San Diego Downtown|
|Venue Phone:||(888) 717-2436|
|Venue Type:||Indoor - Hotel|
|Booth Size||Booth Cost||Available Amenities|
|Call for information.||Electricity:||n/a|
|Marketing Vehicles Allowed:||Call|
|Other Booth Sizes Available: n/a|
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