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Navigating the Medical Device Post-Market Maze and Challenges during COVID-19 Pandemic - Learn what FDA is really thinking on regulation and guidance documents  

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training seminars by ComplianceOnline ComplianceOnline

Navigating the Medical Device Post-Market Maze and Challenges during COVID-19 Pandemic - Learn what FDA is really thinking on regulation and guidance documents seminar agenda print utility

dates/locations

For:

Regulatory Affairs, QA/QC, Project Managers, Regulatory Professional, Risk Managers, Complaint Handling Teams, CAPA Teams

Cost:   

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Seminar Summary:

Medical Device Reporting (MDR), and Recall compliance are critical to the continue survival of all device manufacturers. (see full course description)

 

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Training Course Syllabus:


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.

By attending this seminar, you will 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
  • How and when to file Medical Device Reports (MDR), effective and appropriate communication with the appropriate regulatory agencies in the event of a recall.
  • 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 Complaint 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
  • Step-By-Step guide to designing Standard Operating Systems for communicating process for firm’s success
  • Discussion of FDA’s New Guidance’s on Risk and how it interacts with Recalls

Seminar Summary:

Medical Device Reporting (MDR), and Recall compliance are critical to the continue survival of all device manufacturers. (see full course description)

 

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