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Surviving an FDA Inspection -- FDA Inspections of Non-U.S. Sites

  January 10, 2018  
CfPA-The Center for Professional Advancement, Amsterdam, The Netherlands
4-5 June 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:

  • Top Management
  • Quality Assurance/Control
  • Regulatory Affairs
  • Auditing
  • Engineering
  • Research & Development
  • Quality Systems Management
  • Documentation Management

The course will focus on various types of inspections in the pharmaceutical, medical device and related industries and will look at policies, procedures and experiences relevant to those inspections.

Course Description
This course provides an overview of the FDA inspection process in general and of particulars applicable to “foreign inspections”. It provides a background and understanding of the role played by the Agency, its administrative and enforcement powers. The course provides a step by step description of the inspectional process with specific examples regarding cGMP compliance inspections and pre-approval inspections.

The latest FDA initiatives regarding inspections, like risk based approach and system based approach, will be discussed in detail. This will enable participants to better understand how to prepare their companies for FDA inspections.

The course consists of lectures, discussions, case studies analysis, and a hands-on workshop in setting up a company procedure for handling 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 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
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