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 To Respond To FDA 483s

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

Brian G. Nadel

President

Brian G. Nadel GMP Consulting LLC

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Short Abstract

We are pleased to announce the premier edition of ‘Response to 483s’ Webinar. As you will agree, responding to 483s is one of the major challenges being faced by Quality Heads from pharmaceutical companies. With the USFDA keeping a close check on observations in a Pharma facility, it is imperative that we provide knowledge on best practices to respond effectively and sincerely to a 483 being issued by the USFDA.

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Program Agenda

8:30 AM – 09:00 AM Spot Registration + Breakfast + Introduction
09:00 AM - 10:30 AM Recent trends and Review of 483s :
  • Enlisting the problems and assigning a solution to each of it
  • Trend analysis
  • Recovery options from an FDA 483
10:30 AM - 10:45 AM Tea/Coffee Break
10:50 AM - 12:00 PM Devising a CAPA for your 483 :
  • Root Cause Identification to understand where the problem lies and linking it to QMS
  • Impact Assessment
  • Devising a strong CAPA
  • Effective checks on CAPA
12:00 PM - 01:00 PM Lunch
01:00 PM - 02:30 PM Continuity and commitment after writing a thorough response
  • Thinking like the FDA
  • Relating observations to the apt Quality Management System
  • Getting ready for the next audit – Do’s and dont’s considering your 483 inspection
  • Best practises to devise a sincere response with a follow up plan
02:30 PM - 03:00 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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