Course Description

Preparing for and Surviving an FDA Inspection

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Course ID 187

In-Person Course

Who Should Attend?
This comprehensive course is intended for individuals whose functions have direct or indirect involvement with FDA inspections. These functions include among others:
  • Executive Management
  • Quality Assurance/Quality Control
  • Regulatory Affairs
  • Research and Development
  • Auditing
  • Engineering
  • Documentation Management
  • Technical Services
  • Plant Management
  • Laboratory Operations

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’Ts
  • 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 opportunities for participant interaction.

“Renee [Galkin] was an excellent presenter and had a wealth of knowledge. This was a very interactive class. I was never bored and it was never over my head. Very practical. I received a lot of information that I did not have previously.“
E.W., Quality Assurance Specialist, KAO Corporation

Course Director
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.

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