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PDA Parenterals Conference
From 26-28 October, 2010 the PDA Parenterals Conference will be held in Berlin.
This outstanding event will cover the very important topics:
- Future of Parenterals
- Packaging and Impact on Quality
- Manufacturing Flexibility and Control
- Innovative Plants
- Monitoring Technologies
- Medical and Application Devices
- Regulatory Trends
Don´t miss this interesting conference in Berlin, Germany.
News about GMP/cGMP
FDA doubles foreign inspections
Brian Hasselbalch, Team Leader, Guidance and Policy Team, Office of Compliance, CDER, FDA, told the audience at the PDA FDA Regulatory Joint Conference 2009 in Washington yesterday that the number of inspections in overseas will double in 2009. In 2008 FDA made approx. 45 foreign inspections for routine surveillance. The goal for 2009 is 100 inspections. And in 2010 the number of inspections will not decline.
One of the reasons is the increasing risk in overseas manufacturing sites. API manufacturers (acitve pharmaceutical ingredients) are also in the focus as finished pharmaceuticals.
Thomas Peither, President of Maas & Peither America, visited the conference and presented the GMP MANUAL as a leading global GMP knowledge system for the pharmaceutical industry.
Source: PDA FDA Regulatory Joint Conference 2009, September 14-16, 2009