Never ever a 483?
We can not promise that you will never get a 483
but we know that the GMP MANUAL includes all
procedures and processes you need to be
GMP compliant.
Newsletter registration
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
FDAs Risk Communication
This new "Strategic Plan for Risk Communication" is another step to get more transparent for the public. We noticed this openness already at the recent PDA/FDA Joint Regulatory Conference in Washington where the FDA discussed a lot of issues in a very open minded way.
We are convinced that this is a very important step to strengthen the reliability between agency and industry.