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More than 400 GMP guidelines, e.g. from FDA, EU, ICH, GHTF, PIC/S,
are on the CD-ROM. This unique GMP tool cannot be purchased. The CD-ROM is
a free service provided to participants who join one of the events
organised by the European Compliance Academy (ECA) in co-operation with
CONCEPT HEIDELBERG.
The CD GMP Navigator is a yearly published CD with
the current worldwide GMP regulations. An easy-to-use navigation system
allows the user to open the "library of guidances".
Thousands of pages are easily accessible. The
easy-to-handle search function will give immediate answers to the
questions: Which guidances and regulations contain statements on water for
injection, cleaning validation, stability testing or any other GMP topic
you are searching for?
The new version 7.0 has been updated with the latest
GMP regulations. Also all GMP-relevant FDA warning letters are included on
the CD-ROM. This allows you to search for frequently observed
deficiencies.
In addition to FDA summaries and presentations,
industry recommendations have also been added on the latest update 7.0.
E.g. the Active Pharmaceutical Ingredient Committee (APIC) has published
several guidances on ICH Q7A compliance (e.g. ICH Q7A How to do, Cleaning
Validation, Technical Change Control Guideline).
If you join one of the future ECA/CONCEPT HEIDELBERG
events, the CD will be part of your conference documentation!
All ECA Members also have the opportunity to have
access to the online database by visiting the Members Area at www.gmp-compliance.org.
If you would like to read more about the CD-ROM GMP Navigator, click
here.
Author:
Oliver Schmidt
CONCEPT HEIDELBERG
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