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Navigating the Maze for Post-Market Compliance -- Complaint Handling, MDRs, Recalls and Proposed Guidance on FDA Risk Benefits

ComplianceOnline

Thursday, February 2, 2017 at 8:30 AM - Friday, February 3, 2017 at 12:00 PM (EST)

Navigating the Maze for Post-Market Compliance --...

Ticket Information

Ticket Type Sales End Price Fee Quantity
Seminar One Registration (Early Bird Price)
Registrations after January 20, 2017 - $1899
Feb 2, 2017 $1,499.00 $0.00
Seminar One Registration Feb 2, 2017 $1,899.00 $0.00

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Event Details

This interactive One and a half day course lead by FDA’s recently retired CDRH Recall Branch Chief Rita Hoffman who has more than 36 years’ experience in FDA compliance issues will provide the participants tools to minimize risk of regulatory enforcement actions.

During the seminar, she 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.

Seminar Instructor, Ms. Rita Hoffman is the former FDA CDRH Recall Branch Chief and has more than 36 years of FDA experience across the device, drug and veterinary industries.

 

Medical Device Reporting (MDR) and recall compliance are critical to the continue survival of all device manufacturers. The FDA is continuing their efforts to issue numerous FDA Warning Letters and serious enforcement actions, including criminal & civil penalties levied on companies that failed to properly report events and take proper corrective and removal actions. The number of device companies having their recall classified as a Class 1 (most severe) recall has surged in the past three years. Additionally, product liability and financial risks are staggering when companies fail to properly report and take action when required. This course will provide an understanding of MDR & recall compliance and the interrelationship of Complaint Handling, CAPA, and Risk Management processes. It will be beneficial to all device manufacturers and is recommended for any individuals or teams that are involved in medical device reporting (MDR) and correction & removal processes, including recalls.

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.
  • Assist with the creation and maintenance of effective procedures for handling complaints, reportable events and recalls.
  • Understand the relationship and interaction with other quality system elements as they relate to complaints and reportable events.
  • Walk-through of case examples.

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
  • Complaint Handling Teams
  • CAPA Teams


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

 

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

Have questions about Navigating the Maze for Post-Market Compliance -- Complaint Handling, MDRs, Recalls and Proposed Guidance on FDA Risk Benefits? Contact ComplianceOnline

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When & Where


Tampa

Tampa, FL

Thursday, February 2, 2017 at 8:30 AM - Friday, February 3, 2017 at 12:00 PM (EST)


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Organizer

ComplianceOnline

Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.

Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.

Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.

Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.

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Navigating the Maze for Post-Market Compliance -- Complaint Handling, MDRs, Recalls and Proposed Guidance on FDA Risk Benefits
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