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NJHA Conference & Event Center
760 Alexander Road, PO Box 1
Princeton, New Jersey

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Live Corporate Seminar

International Seminar on Complaint and Adverse Event Management

insert_invitation Thursday, 21st December, 2017
access_time 09:00 AM - 01:00 PM EST |
timelapse with 30 mins of Q and A

Note:

Post session, copy of presentation slides will be shared

Speaker/Presenter

Jeff Kasoff, RAC, CQM/OE

Quality and Regulatory Affairs

Consultant

Short Abstract

The objective of this course is to expertise you how to handle compliant , from clear understanding of regulatory requirements to Complaint Review and Trending.

The session will focus on uderstanding Complaint and Adverse Event Management: A Compliant, Lean Program


Apply for this Seminar

Program Agenda

8:30 AM – 09:00 AM Spot Registration + Breakfast + Introduction
09:00 AM - 09:30 AM Complaint Handling :
  • Regulatory Overview: FDA, ISO 13485 (including 13485:2016)
  • Definitions
  • Application of Definitions
  • ....
09:30 AM - 10:00 AM Tea/Coffee Break
10:00 AM - 11:00 PM ...
  • The Value of “Non-complaints
  • Complaint Triage and Handling
  • Complaint Investigations
  • How to Avoid “Death by CAPA”
  • “Closing” Complaints
  • Contents of Complaint Form
  • Complaint Review and Trending
  • Implementation of Risk Management into Complaint Handling
  • Common Pitfalls and How to Overcome Them
  • Exercise: Complaint or Non-complaint?
11:00 AM - 11:30 AM Adverse Event Reporting
  • Regulatory Overview: FDA, MDD
  • MDRs
    • Reporting Process
    • Reporting Requirements
  • Vigilance Reports
    • Reporting Process
    • Reporting Requirements
  • Exercise: Reportability of Events
11:30 AM - 12:30 PM Recalls / Field Corrective Actions
  • Regulatory Overview: FDA, MEDDEV, Health Canada
    • FDA Regulations
    • EU Requirements
    • Competent Authority Reportable Events
    • Reporting Requirements
  • Corrections and Removals
  • Market Withdrawal and Stock Recovery
  • Recall Classifications
  • Roles and Responsibilities
12:30 PM - 01:00 PM Q&A – Conclusion

Registration Information

  • Registration Fee : USD $499
  • For assistance on registration, please send an email to marketing@biopractice.com or Please call: Ph - 1-646-216-8860
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