home   genetic news   bioinformatics   biotechnology   literature   journals   ethics   positions   events   sitemap
 
  HUM-MOLGEN -> Events -> Courses and Workshops
Search  -  prev / next
 
 

Preparing for and Surviving an FDA Inspection

 
  October 30, 2017  
     
 
CfPA-The Center of Professional Advancement, New Brunswick, NJ
March 19-20, 2018


Who Should Attend?
This overview course is intended for individuals whose functions have direct or indirect involvement with FDA inspections. These functions include among others:

  • Executive Management 
  • Regulatory Affairs 
  • Auditing 
  • Documentation Management
  • Plant Management
  • Quality Assurance
  • Quality Control
  • Research and Development
  • Engineering
  • Technical Services

Course Description
This course provides background and understanding of the role played by the Agency, its administrative and enforcement powers. It takes the participant step by step through the entire inspection process and describes various types of inspections.

The course offers methodologies and techniques on:
  • How a firm should prepare for an FDA inspection
  • Ways to train employees in view of the inspection
  • How to ensure that required documentation is in place
  • How to interact with the investigator—DO’s and DON’T’s
  • What companies should do when the inspection ends
  • How to reply to 483’s and warning letters
  • Legal implications of non-compliance
  • Post inspection actions

The course consists of lectures, discussions and a practical workshop which will enable participants to work in small groups and design a company procedure for handling FDA inspections.
 
 
Organized by: CFPA-The Center of Professional Advancement
Invited Speakers:
Renée B. Galkin; Quality Management Consultant

Renée B. Galkin is a quality management consultant with over 30 years experience in the pharmaceutical and device industries.

Prior to starting her consulting business, Ms. Galkin was part of two major companies: Science Management Corporation – a multinational consulting firm and then Wyeth/Pfizer where she gained her pharmaceutical experience during her 20 year association. Throughout her career Ms. Galkin held both domestic and international assignments.

Ms. Galkin has an MBA in Business Management from New York University, an MA in Education and Science from Brown University and a Bachelor of Science in Biology from Northeastern University. She is a member of the American Society for Quality, the Parenteral Drug Association and the International Society for Pharmaceutical Engineering (ISPE). She is also a Certified Quality Auditor.

As a consultant, Ms. Galkin has been providing training and consulting advice to pharmaceutical and medical device companies in the United States and Europe in areas related to consent decrees, pre-approval and regular FDA inspections, audit programs, quality systems requirements, documentation systems management, validation, supplier selection and management.

She also directs several technical courses offered by the Center for Professional Advancement. Participants at her courses enjoy and appreciate her interactive and personal teaching style which keeps the audience alert and constantly involved.
 
Deadline for Abstracts: n/a
 
Registration: Please click here for registration information.
E-mail: Jmorbit@cfpa.com
 
 
   
 
home   genetic news   bioinformatics   biotechnology   literature   journals   ethics   positions   events   sitemap
 
 
 

Generated by meetings and positions 5.0 by Kai Garlipp
WWW: Kai Garlipp, Frank S. Zollmann.
7.0 © 1995-2018 HUM-MOLGEN. All rights reserved. Liability, Copyright and Imprint.