Issues with Risk Assessments for Parenteral Facilities
April 27, 2015 - Fremont CA USMentorHealth
webinars@mentorhealth.com
Phone:8003851607
Fax:302-288-6884
Overview: Parenterals are the easiest of the dosage forms to be controlled and the webinar will show why this is. The webinar will explore the typical processes used in parenterals and will look at the advantages of single use product contact surfaces as opposed to dedication and the use of common parts which are clean often manually and using a non hazard based limit. We will look at facility, HVAC and equipment issues. Why should you attend: Based on a parenteral route of exposure would provide 100% bio-availability the EU regulators believe they are the greatest risk. All the data we have collected shows this to be an erroneous view. This case will be illustrated by Data and an explanation made as to why OSD is is the greatest Risk. 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 Setting Limits ADE and PDE (declared synonymous by the EU) Why Parenterals are not a problem, viable versus non viable particles HVAC Disposables versus dedication or Shared equipment The issues with Lyophilizers 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. MentorHealth Roger Steven contact no: 8003851607 fax no: 302-288-6884 Event Link:http://bit.ly/1EdheOU webinars@mentorhealth.com www.mentorhealth.com