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Auditing for GMP Compliance

 
  May 20, 2013  
     
 
CfPA - The Center for Professional Advancement, Amsterdam, The Netherlands
13-15 November 2013


Who Should Attend
This overview, practical course is designed for those auditors who have recently been involved or expect to be involved in internal or external GMP audits.

The program will benefit individuals in the pharmaceutical, medical device and related industries like diagnostics, cosmetics, food, biotechnology as well as vendors, suppliers and contract organizations.

The course can be of interest to top management responsible for GMP audit programs in their companies as well as to professionals in a variety of functions such as:

  • QA/QC 
  • Laboratories
  • R&D 
  • Production
  • Regulatory Compliance 
  • Packaging
  • Engineering 
  • Documentation Management

Description
GMP regulations worldwide as well as FDA and ICH guidances require that companies have in place an internal quality audit program. Auditing is also a powerful management tool in establishing how effectively a company controls the quality of its products and ensures compliance.

The program will deal primarily with auditing tools and techniques needed when conducting effective internal and external GMP audits.

This practical course will consist of lectures, interactive discussions and hands-on workshops including a role playing session.

 

 
 
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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