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

cGMP Quality Principles for Pharmaceuticals, Biopharmaceuticals, Biologics and Medical Devices

 
  December 20, 2013  
     
 
Center for Professional Innovation & Education, Inc., Malvern, PA
Mar. 31 – Apr. 2, 2014


This course will provide the participant knowledge of current GMPs, how they are applied in the Bio/Pharmaceutical market today, and how they will be enforced in the future.

Topics included are:

  • Impact of facility and equipment design on GMP compliance
  • Risk management approach to compliance
  • Vendors
  • Commissioning, Qualification and Validation – Which one to use
  • Problem resolution
  • Part 11 in production and the laboratory

A comparison between 21 CFR 210/211, 600, and 810 as well as ICH guidelines will be made as they affect combination products, normal Bio/Pharmaceuticals, and Medical Devices. Current "hot" topics and examples of recent warning letters will also be discussed and evaluated.

This course has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for 12 credits towards a participant's RAC recertification upon full completion.

 
 
Organized by: Center for Professional Innovation & Education
Invited Speakers: Contact info@cfpie.com for a list of course instructors
 
Deadline for Abstracts: n/a
 
Registration: http://www.cfpie.com/showitem.aspx?productid=095&source=hummolgen
E-mail: info@cfpie.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.