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 How FDA Trains Its Investigators to Review CAPA

timelapse Full Day followed by Breakfast & Lunch
with 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 provide the tools you need to develop and implement a compliant and effective CAPA system, from clear understanding of regulatory requirements to accurate root cause determination to confirmation of CAPA effectiveness.

The session will focus on uderstanding CAPA and will discuss about the Elements of a Corrective Action Program

Get this seminar

Program Agenda

8:30 AM – 09:00 AM Spot Registration + Breakfast + Introduction
09:00 AM - 10:30 AM Understanding CAPA :
  • Review of Regulations
  • Definitions
  • Where/When is CAPA Required
10:30 AM - 10:45 AM Tea/Coffee Break
10:45 AM - 12:15 PM Elements of a Corrective Action Program :
  • Essential SOPs and Other Documentation
  • Detection of nonconformance
  • Identification of cause (Investigation)
  • Review of Investigation
  • Determination of Corrective/Preventive Action
  • Performance of Corrective Action
  • Implementation of Corrective Action
  • Effectiveness of Corrective Action
  • Common Misconceptions
12:15 PM - 01:15 PM Lunch
01:15 PM - 02:45 PM Root Cause Analysis
Sources of, and Application of, CAPA
02:45 PM - 03:00 PM PM Break
03:00 PM - 04:45 PM How FDA Trains its Investigators to Review CAPA, and Recommended Compliance Methods
Fun and Games with CAPA: A Mini-Workshop
04:45 PM - 05:00 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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