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Conducting Effective Quality Audits

  December 05, 2016  
CfPA-The Center for Professional Advancement, New Brunswick, NJ
October 24-26, 2017

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

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

The course can be of interest to top management responsible for audit programs in their companies as well as to professionals in a variety of functions such as:
  • QA & QC 
  • Laboratory
  • R & D 
  • Production
  • Regulatory 
  • Toxicology
  • Documentation Management 
  • Clinical Research
  • Packaging 
  • Purchasing

RAPS - Regulatory Affairs Professional Society 
This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's recertification of their Regulatory Affairs Certification (RAC) upon full completion.

Course Description
Auditing is a powerful management tool in establishing how effectively a company controls the quality of its products and ensures compliance.

This hands-on, practical course will deal primarily with auditing tools and techniques which are applicable to any industry or function. A quick overview of requirements for an audit program in pre-clinical and clinical operations will be provided. Specific examples will cover auditing certain aspects of drug and medical device operations for compliance with cGMP.

The course will consist of lectures, discussions, exercises, workshops and a role-playing session involving a simulated compliance audit.
Organized by: CfPA-The Center for Professional Advancement
Invited Speakers:
Course Director
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: Jmorbit@cfpa.com
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