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

 
  December 18, 2013  
     
 
CfPA - The Center for Professional Advancement, Amsterdam, The Netherlands
16-17 June 2014


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.

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 policy/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 twenty years experience in the pharmaceutical and medical device industries. Her areas of expertise include quality audits, quality programs, FDA regulatory compliance, cGMP 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, the International Society for Pharmaceutical Engineering (ISPE) and is fluent in French. 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 (CfPA).
 
Deadline for Abstracts: n/a
 
Registration: Please click here for registration information.
E-mail: sberg@cfpa.com
 
   
 
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