November 20, 2009 WEBINAR
Noon-1:30 pm EST
Companies with Multiproduct facilities are at risk from the regulator, the FDA has cut the response time to 483’s to 15 days before enforcement action can proceed. This seminar looks at these risks and how to face them. The trouble is that in the main both sides use perception qualitative statements that are not based in science. This seminar reviews these issues and shows how much current thinking in facility design leads to unnecessary cost for no demonstrable benefit.
The talk is illustrated by data gained over many projects.
In this webinar you will learn about:
· Major Causes of Observation
· Why this is a vital topic
· Regulatory Issues
· Quality
· FDA’s Six Systems of Control
· Major causes of observations
· Risk, Hazard and Exposure
· Variables to be Controlled
· Facilities: Upgrades and Energy Costs
· Facility Design Concepts
· HVAC : What Works and Doesn’t Work
· Airlocks : Essential or Costly and Unnecessary
· Engineering Controls and Over Engineering
· Process Integration
· Ergonomics and Material Handling
· Mix Up and Why it is a Cause of Observations
· Quality Risk Management Plans
· QRMP
