Join us and celebrate the 20 years anniversary of ECA in Heidelberg at the 8th European GMP Conference - Meet speakers from US FDA, EU GMP Inspectorates and Pharmaceutical Industry to hear the latest GMP Trends - Receive the latest ECA Guidance Documents at no costs!
From 9-10 April 2019 in Düsseldorf, Germany - More than 60 Speakers from pharmaceutical companies and GMP Inspectorates - Case Studies from Novartis, Roche, Boehringer Ingelheim, Sanofi, Bayer, Pfizer and many more - 3 GMP/FDA Conferences – create your own agenda!
With news, trainings and conferences, a comprehensive guidelines database, publications and more the ECA is the leading European training and information services provider in the GMP and GDP environment.
The topic data integrity generates a multitude of questions. Current questions are answered in a loose sequence of News. Question 2: Is the Audit Trail review required by the authorities before each batch release, or is it only recommended?
In February 2019, the FDA published a new draft guideline that addresses quality aspects of continuous pharmaceutical manufacturing. It covers topics related to development, process validation, marketing authorisation and routine production.