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

Avoiding GMP non-Compliance Due to Raw Material Issues

  August 08, 2012  
ComplianceOnline, Online Event

Areas Covered:

  • FDA requirements for raw material management at GMP facilities
  • Common risk management practices
  • Vendor selection and validation requirements
  • Product specific raw material issues: chemical, biologic and botanical raw materials
  • Suggested quality control measures
  • FDA’s common findings and possible resolutions
  • Trends in FDA inspection of raw material processes
  • Regional and multinational raw material providers
  • Raw material risk management in the global setting
Event Details:
Date:                    September 11, 2012
Time:                    10:00 AM-11:00 AM PDT
Cost:                    $249 per attendee per computer terminal
Registration:        SIgn-Up on-line now.  Add to your shopping cart.

Organized by: ComplianceOnline
Invited Speakers: Dr. Mukesh Kumar leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD. His key expertise is in regulatory affairs, clinical trials and multi-national project management for medicinal and diagnostic products. He has been involved in about 100 clinical trials in more than 40 countries, has made several hundred US FDA submissions, and arranged a number of meetings with the US FDA. In addition, he has had made regulatory submission in the EU and India.
Deadline for Abstracts: 2012-09-11
Registration: http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=702282?channel=hummolgen
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.