New Version 7.0 of the CD-ROM GMP Navigator Has Been Released

GMP News No. 553

GMP News
11 May 2005

 

NewVersion 7.0 of the CD-ROM GMP Navigator Has Been Released

 
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 isa free service provided to participants who join one of the eventsorganised by the European Compliance Academy (ECA) in co-operation withCONCEPT HEIDELBERG.

The CD GMP Navigator is a yearly published CD withthe current worldwide GMP regulations. An easy-to-use navigation systemallows the user to open the "library of guidances".

Thousands of pages are easily accessible. Theeasy-to-handle search function will give immediate answers to thequestions: Which guidances and regulations contain statements on water forinjection, cleaning validation, stability testing or any other GMP topicyou are searching for?

The new version 7.0 has been updated with the latestGMP regulations. Also all GMP-relevant FDA warning letters are included onthe CD-ROM. This allows you to search for frequently observeddeficiencies.

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 publishedseveral guidances on ICH Q7A compliance (e.g. ICH Q7A How to do, CleaningValidation, Technical Change Control Guideline).

If you join one of the future ECA/CONCEPT HEIDELBERGevents, the CD will be part of your conference documentation!

All ECA Members also have the opportunity to haveaccess to the online database by visiting the Members Area at www.gmp-compliance.org.

 

Author:
Oliver Schmidt
CONCEPT HEIDELBERG
 

 

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