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
ICH Q8,9,10 Workshops
Calendar the three following dates:
Europe: 2-4 June 2010 Tallinn, Estonia
USA: 6-8 October 2010 Washington, DC
Japan: 25-27 October 2010 Tokyo
Workshop Content
Practical training on integrated implementation of Q8, Q9 and Q10 in pharmaceutical development, manufacturing, regulatory assessment, scale up to commercial operation, and GMP-inspection. This is an opportunity for open dialogue among industry and regulators on:
- Comprehensive training on regulatory aspects, technical development and manufacturing
- Case study combining Q8, Q9 and Q10
- Regulatory topics related to submission expectations and GMP-inspections
Faculty
Regulator and Industry experts serving the ICH Q-IWG and experts involved in development of the ICH Q8, Q9 and Q10 guidances.
Who should attend
Workshops are open to all persons having interest in practical implementation of ICH Q8, Q9 and Q10, including regulators (assessors and GMP-inspectors) and industry (all disciplines).
Workshop Feedback
Information from the workshops will be used by ICH Q-IWG to support the harmonised implementation of ICH Q8, Q9 and Q10. Workshop materials are suitable for internal training by industry and regulators.
Links
ISPE/ Announcement