Issues with Risk Assessments for Cross Contamination of OSD Facilities

MessageThis Webinar is over
Date Feb 24, 2015
Time 01:00 PM EDT
Cost $139.00
Overview: Oral Solid Dosage is the most difficult of the pharmaceutical processes to protect from cross contamination and the webinar will show why this is. The webinar will explore the typical processes used in Oral Solid Dosage. Equipment issues will be explored and critical issues outlined We will look at facility, HVAC and equipment issues. 

Why should you attend: Using data the case for OSD being outstandingly the greatest risk will be made and the reasoning explained 

If you are a CMO it will help to get you ahead of what is about to happen staring March 1st 2015.

The routes of cross contamination will be reviewed with emphasis on cleaning due the high surface to volume ratios encountered.

The majority of CMO' we interact with do not understand what is happening and why they need to plan for the new requirements even if they do not supply the EU. As part of the webinar a brief review of what is happening with regulators around the world be included. 

Areas Covered in the Session:
  • Briefly review the new regulations
  • Why Oral Solid Dose is a problem
  • The importance of boundaries in facility design
  • The importance of HVAC
  • Why liquids are so much easier that powders
  • Closing powder handling processes
  • It's not just about cleaning

Who Will Benefit:
  • Directors
  • Senior Managers in the Quality and Regulatory Areas
  • Senior Managers of Operations
  • Engineering and for CMO Business Development Leadership

Julian Wilkins was educated as an Architect in the United Kingdom.. He practiced as an architect and project team manager for IDC now AMEC from 1972 to 1988. From 1978 onwards all the projects he handled where for the pharmaceutical industry. 

In 1990 he co-founded an isolator company in the United Kingdom, which became part of what is now Bioquell. The company undertook many ground breaking projects in pharmaceutical containment for Merck, Glaxo, Cyanamid, Wyeth, etc. 

Roger Steven
contact no: 8003851607
fax no: 302-288-6884
Event Link:


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