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EVENT DATE
Jun 2016
M T W T F S S
13141516171819
EXPO DATE
Jun 2016
M T W T F S S
13141516171819

Venue

Double Tree San Diego Downtown 1646 Front Street
San Diego , CA 92101
Location map
Type: Indoor - Hotel

Partners

exhibitus success by design Remington Hotels NorthStar Express Freight

Post-Market Compliance for Medical Devices and Evolving Reporting Requirements: Complaint Handling, MDR/eMDR and Recalls including UDI update

Double Tree San Diego Downtown
B2B 30

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
QA/QC
Project Managers
Regulatory Professional
Risk Managers

 

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

For Registration:
http://www.complianceonline.com/complaint-handling-medical-device-reporting-and-recalls-seminar-training-80068SEM-prdsm?channel=eventsinamerica

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.

EVENT CONTACTS


Referral
ComplianceOnline
2600 E. Bayshore Road
Palo Alto, CA 94303
(888) 717-2436

EVENT DETAILS

Primary Industry:
Medical
Other Industries:
Manufacturing, Medical
Audience:
Regulatory Affairs
QA/QC
Project Managers
Regulatory Professional
Risk Managers
Complaint Handling Teams
CAPA Teams
Notes:
Attendee Statistics:
Show Owner:
ComplianceOnline
Sponsorship:

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