Risk Assessments 2015 - The Need for Quantitative Data to Justify Risk Assessments

Overview: The webinar looks at the ways in which data can be collected at reasonable cost to clearly indicate if cross contamination is occurring. With the ADE and PD now firmly established and with the EU's recognition that both are synonymous there is now a scientific hazard based limit for use in all calculations to show compliance or non-compliance with the new GMP's I also shows how a wide range of data can be used to help qualitative assessments. Real data from companies who have undergone this process, often under regulatory scrutiny is used illustrate case studies.
Why should you attend: The new EU regulations come into force on March 1st. 2015 and observations already show how the EU intends to enforce the new regulation from the start. It should be noted that the EU completely ignored the EFPIA (European pharmaceutical manufacturers association) representations of September 2013
Areas Covered in the Session:
The new regulations and how they came about
The use of data to determine if cross contamination is occurring
The reality of OSD versus Parenteral
The problems of Mechanical transfer
How to calculate the Exposure holistically
Why it not just about cleaning
Real world results
Who Will Benefit:
Directors
Senior Managers in the Quality and Regulatory Areas
Senior Managers of Operations
Engineering and for CMO Business Development Leadership
MentorHealth
Roger Steven
contact no: 8003851607
fax no: 302-288-6884
Event Link:http://bit.ly/1voBueZ
webinars-AT-mentorhealth.com
www.mentorhealth.com