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Site language : English - Français
Ref : 30726
Event :4-Hr Virtual Training: How to Respond to an FDA Investigation

Date :Wednesday December 04th, 2019

Location :Palo Alto
2479 East Bayshore Road,
Suite 200
94303 Palo Alto, United States

Type :Conference & Seminar - International audience

Accreditation :--


 

Further information

Editorial

This FDA investigation training program will deconstruct best practices for handling unannounced FDA visits, responding to a 483 or a warning letter, and the effect of an FDA investigation. The program will also discuss basic concepts that should be employed by everyone regulated by the FDA and define processes for preparing for FDA audits.
 

Objectives

  • What should a company do if the FDA shows up unannounced
  • How should a company respond to 483 observations or a warning letter
  • The effect an FDA investigation can have on a company
  • The basic concepts that should be employed by everyone regulated by the FDA
  • How a company can prepare for situations like this
  • Lesson learned
  • How a company can balance the need to prepare for a potential FDA investigation or enforcement action and still run a profitable business

 

Program

  • Quality Assurance Staff
  • Quality Control Staff
  • Engineers
  • IT Staff
  • Manufacturing Supervisors and Managers
  • Documentation Staff
  • Directors, Managers, Supervisors

Speakers

Principle Consultant, Maynard Consulting Company
 

Location

Map and directions
Conference address :
Palo Alto
2479 East Bayshore Road,
Suite 200
94303 Palo Alto
United States
tel : +1-888-717-2436
Map and directions

Further information

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Details

4-Hr Virtual Training: How to Respond to an FDA Investigation Management
"fda investigation training program, unannounced fda visits, responding to 483s, preparing for fda audits"
Professionals
3 -- --
English

Other

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