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
FDA: Improvement of Guidance Development Process
Transcripts and summaries of those listening sessions are available online and FDAs is seeking comments from the public on the issues raised in those sessions, or other suggestions related to FDA's transparency to regulated industry.
Outcome:
If you are interessted in FDAs development, check the documents provided. If you like to participate: FDAs next question is: What changes, if any, should FDA make to its guidance development process? For futher information check the Transparency Initiative's Website.
Link:
FDA/ Announcement