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Preparing for and Surviving an FDA Inspection

  November 15, 2012  
CfPA - The Center for Professional Advancement, Burlingame, CA
April 17-18, 2013

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:

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

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 for Professional Advancement
Invited Speakers: Renée B. Galkin; Quality Management Consultant

Renée B. Galkin is a quality management consultant with over twenty years experience in the pharmaceutical and medical device industries. Her areas of expertise include quality audits, quality programs, FDA regulatory compliance, GMP training, documentation systems management, strategic planning and organizational development.

Prior to starting her own consulting business, Ms. Galkin held managerial positions with two major companies – Wyeth Pharmaceuticals, Inc. (now Pfizer) and Science Management Corporation (a multinational consulting firm). Throughout her career she had both domestic and international assignments.

Ms. Galkin holds an MBA in Business Management from New York University, an MA in Education 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). As a consultant, Ms. Galkin provides training, auditing and compliance advisory services to companies worldwide. She also directs several technical courses offered by The Center for Professional Advancement.
Deadline for Abstracts: n/a
Registration: Please click here for registration information.
E-mail: sberg@cfpa.com
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