home   genetic news   bioinformatics   biotechnology   literature   journals   ethics   positions   events   sitemap
 
  HUM-MOLGEN -> Events -> Courses and Workshops
Search  -  prev / next
 
 

Conducting Effective Quality Audits

 
  July 07, 2017  
     
 
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:
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
Bookmark and Share this page (what is this?)

Social bookmarking allows users to save and categorise a personal collection of bookmarks and share them with others. This is different to using your own browser bookmarks which are available using the menus within your web browser.

Use the links below to share this article on the social bookmarking site of your choice.

Read more about social bookmarking at Wikipedia - Social Bookmarking

 
 
   
 
home   genetic news   bioinformatics   biotechnology   literature   journals   ethics   positions   events   sitemap
 
 
 

Generated by meetings and positions 5.0 by Kai Garlipp
WWW: Kai Garlipp, Frank S. Zollmann.
7.0 © 1995-2017 HUM-MOLGEN. All rights reserved. Liability, Copyright and Imprint.