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

Pharmaceutical Quality Assurance and Control

 
  July 02, 2007  
     
 
The Center for Professional Advancement, New Brunswick, NJ
October 15-19, 2007


Who Should Attend:
This course will benefit those who need to know how quality can be assured and controlled in the production of pharmaceuticals and related products. The material is particularly suitable for chemists, pharmacists, engineers and administrators working in the following areas:

R&D
Purchasing
QA
Engineering
QC
Maintenance
Regulatory Affairs
Corporate/Plant
Plant Operations Management

The course will also benefit personnel in Regulatory Agencies and Suppliers to the Industry.


Description:
This course provides an understanding of the principles and practice of pharmaceutical quality assurance and control and of specific topics which have become important because of regulatory interest or recent technological achievements. Throughout the course an emphasis is placed upon quality as viewed on a cost/benefit basis as well as a cGMP basis.

The first day provides an understanding of the basic principles and practice of the QA and QC functions, covering their role during product design, production and revision, with the role in production being dealt with in particular detail. The second, third and fourth days consist of reviews, first of broad current quality issues including FDA activities, and then the QA/QC aspects of a number of specific issues including: handling of laboratory controls, validation (equipment, processes, computers, cleaning and test methods), label and labeling, water systems, change control, electronic records and signatures, deviations and discrepancies, (including OOSs), FDA inspections, internal and supplier audits, vendor and contract supplier qualification, annual product reviews, and training. A general question and answer session is also provided. The fifth day is devoted to the QA/QC aspects of stability program operation and also to documentation. The course includes hands-on workshops as well as lectures.

 
 
Organized by: The Center for Professional Advancement
Invited Speakers: Please click here for speaker information.
 
Deadline for Abstracts: not applicable
 
Registration: Please click here for registration information.
E-mail: info@cfpa.com
 
   
 
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- HUM-MOLGEN. All rights reserved. Liability, Copyright and Imprint.