RECORDED SEMINARS

FDA REMS & Post marketing Surveillance Studies
(New laws and Recent Changes t oFDA Approach and the design and conduct of post-marketing surveillance studies)

Tuesday, 25th September, 2012
Time : 01:00 PM | 10:00AM
Requirements for Launching New Products : USA & Internationally &
Biologics in a World with Biosimilars

Tuesday, 30th April, 2013
Time : 09:00 AM - 05:00 PM |

International Seminar on Orphan Drugs & Rare Disease

Thursday, 12th September, 2013
Time : 09:00 AM - 02:00 PM |

Unique executive oversights into biologics and biosimilars including comparability criteria EMA vs FDA, approval strategy and market penetration

Monday, 4th August, 2014
Time : |

International Seminar on How FDA Trains Its Investigators to Review CAPA

Wednesday, 16th November, 2016
Time : 09:00 AM - 05:00 PM EST |

International Seminar on How To Respond To FDA 483s

Friday, 1st September, 2017
Time : 09:00 AM - 03:00 PM EST |

International Seminar on Corrective And Preventive Action In FDA Regulated Industry

Friday, 20th April, 2018
Time : 09:00 AM - 01:00 PM EST |

Executive Update of the US FDA/EU EMA of the New Biosimilars Product Class with Insights into Landmarks, Approval Requirements, Market Penetration & Opportunities

Friday, 14th August, 2015
Time : 09:00 AM - 05:00 PM EDT |

FDA Inspections, Warning Letters, & CAPA 2015 Update

Wednesday, 30th September, 2015
Time : 09:30 AM - 04:30 PM EST |

International Seminar on Protecting Patient Information - It's the Law

Friday, 27th May, 2016
Time : 10:00 AM - 03:00 PM EDT |

International Seminar on FDA Inspections in the 21st Century

Friday, 24th February, 2017
Time : 09:00 AM - 05:00 PM EST |

Supplier Management in FDA-Regulated Industry

Friday, 4th November, 2022
Time : 09:00 AM - 01:00 PM EST |

International Seminar on Complaint and Adverse Event Management

Thursday, 21st December, 2017
Time : 09:00 AM - 01:00 PM EST |

Recorded Seminar

International Seminar on Complaint and Adverse Event Management

timelapse with 30 mins of Q and A

Note:

Recorded Seminar can be played unlimited times
Along with recorded seminar, copy of presentation slides will be shared

Speaker/Presenter

Jeff Kasoff, RAC, CQM/OE

Quality and Regulatory Affairs

Consultant

Know more

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

Get 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 $299
  • For assistance on registration, please send an email to marketing@biopractice.com or
    Please call: Ph - 1-646-216-8860
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