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

How do I Keep FDA Happy with my Contract Manufacturer

  May 22, 2012  
ComplianceOnline, Online Webinar

Why Should You Attend:

No matter where a product is manufactured, quality is the responsibility of the organization whose name appears on the label. If you hire a contract manufacturer to make products that will carry your label and your name, the responsibility for the quality of that product is yours. There are many things that you can do to assure quality and these quality assurance procedures will be covered in this webinar. It should not be necessary to do all of the things that will be discussed - - the secret is to create a system that fits your products, your contractor and your needs. In fact, the quality assurance process may change over time as you learn more about the contract manufacturer you are using and the contractor's commitment to quality.

Areas Covered in the Seminar:

  • Selection of a Contract Manufacturer.
  • Auditing your Contract Manufacturer.
  • Man in the Plant.
  • Contractor's quality procedures.
  • Contractor's analysis of raw materials, in-process, and finished products.
  • Reconciliation.
  • Packaging & Shipping.
  • Linking responsibility to these activities.
  • Batch release.


Organized by: ComplianceOnline
Invited Speakers: James R Harris, PhD has over thirty years of pharmaceutical industry experience in R&D, manufacturing, quality, GMP compliance, validation, and management. He wrote the first FDA approved validation guideline for computerized systems. Following his industry career, Dr. Harris formed a consulting firm with sixty expert consultants who worked with firms around the globe. He has been a frequent speaker at industry meetings around the world and has had papers published in many industry publications and several languages.
Deadline for Abstracts: 2012-05-31

For Registration:


E-mail: referral@complianceonline.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.