chevron_left Categories

Other related webinars

Are Genes Patentable in the United States? (A Re...

Friday, 26th August, 2011
Time : 02:00 PM | 11:00 AM

GLP Regulations – A Simplified Overview for Ac...

Friday, 2nd December, 2011
Time : 02:00 PM | 11:00 AM

Understanding FDA Guidance on GLP for Nonclinica...

Thursday, 22nd December, 2011
Time : 02:00 PM EST | 11:00 AM PST

FDA and EMA successful development and approvals...

Friday, 22nd June, 2012
Time : 02:00 PM EST | 11:00 AM PST

Strategic insights into European (CHMP/EMA) and ...

Monday, 3rd December, 2012
Time : 02:00 PM EST | 11:00 AM PST

FDA Approvals and Insights: Understanding US-FDA...

Friday, 1st March, 2013
Time : 02:00 PM IST | 09:30 AM CET

Effective Responses to FDA Warning Letters on Qu...

Friday, 15th August, 2014
Time : 01:00 PM | 10:00 AM

FDA’s view of Purchasing Controls, regulatory ...

Friday, 3rd October, 2014
Time : 01:00 PM EST | 10:00 AM PST

A review of the FDA’s oversight, regulatory re...

Friday, 16th January, 2015
Time : 01:00 PM EST | 10:00 AM PST

Preparing for and Managing EU Notified Bodies Au...

Thursday, 28th January, 2016
Time : 01:00 PM EDT | 10:00 AM PDT

Biopharmaceutical Method Transfer – Using a Qu...

Friday, 20th May, 2016
Time : 01:00 PM EDT | 10:00 AM PDT

Quality systems for Analytical Instrumentation a...

Friday, 24th June, 2016
Time : 01:00 PM EDT | 10:00 AM PDT

Effective Investigation of Deviations & Putting ...

Friday, 2nd September, 2016
Time : 04:00 PM IST | 11:30 AM BST

NO More Written Procedure (Standard Operating Pr...

Friday, 14th October, 2016
Time : 01:00 PM EDT | 10:00 AM PDT

Best Practices in Supplier Management: Evaluatio...

Friday, 20th January, 2017
Time : 10:00 AM EST | 04:00 PM BST

Using Quality Indicators for Successful FDA QSR ...

Friday, 10th February, 2017
Time : 04:00 PM IST | 11:30 AM BST

Effective Management Reviews for FDA and Managem...

Friday, 21st April, 2017
Time : 01:00 PM EDT | 10:00 AM PDT

FDA Internal Audits - An Important Tool for Avoi...

Friday, 30th June, 2017
Time : 04:00 PM IST | 11:30 AM BST

FDA Regulatory Rules for Supply Chain and Manufa...

Friday, 4th August, 2017
Time : 11:00 AM EDT | 08:00 AM PDT

FDA - Training Modules

Friday, 28th September, 2018
Time : Set the Time | Set the Time

FDA Quality Systems Inspection Technique (QSIT) ...

Friday, 26th October, 2018
Time : 01:00 PM EDT | 10:00 AM PST

Key Element of Quality Management System Complia...

Friday, 30th August, 2019
Time : 04:00 PM IST | 11:30 AM BST

A CAPA Primer - Elements of a CAPA Program

Friday, 28th February, 2020
Time : 01:00 PM EST | 10:00 AM PST

How To Respond To FDA 483s

Wednesday, 2nd March, 2022
Time : 01:00 PM EST | 10:00 AM PST

FDA Expectations from Supplier Management for GM...

Friday, 22nd April, 2022
Time : 01:00 PM EDT | 10:00 AM PDT

The clinical, regulatory and business challenges...

Friday, 19th August, 2022
Time : 01:00 PM EST | 10:30 AM PST

The FDA CGMP and Data Integrity in Pharmaceutica...

Friday, 7th April, 2023
Time : 01:00 PM EST | 10:30 AM PST

FDA PMA Submissions - Contents, Process, Pitfall...

Friday, 21st April, 2023
Time : 01:00 PM IST | 10:00 AM PST

Complaint Handling in Compliance with FDA and IS...

Friday, 26th May, 2023
Time : 01:00 PM EST | 10:00 AM PST

Recorded Webinar

How To Respond To FDA 483s

timelapse 60 Min with 15 Min QnA of Q and A

Note:

This webinar occured in the past
Along with recorded webinar, copy of presentation slides will be shared
Recorded Webinar can be played unlimited times

Speaker/Presenter

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.

Key Areas Covered During the Webinar:

  • Recovery options from an FDA 483
  • 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
  • Discussion will include methods for maintaining a continuous quality improvement program
  • Provide methods for avoiding FDA-483 observations
  • Good Practices on how to verbally respond to FDA-483 observations during the exit meeting


Apply for this webinar

Content Disclaimer

Contents in our website are from external websites. Links to and content from external website are provided for the convenience of users. Biopractice.com takes no responsibility for the content of such links and websites.

//