The GMP requirements on the manufacture of active pharmaceutical ingredients were harmonised not long ago. The interpretation of these requirements is one of the top compliance topics both in the EU and with FDA.

That this topic plays an important role with FDA is proved by the fact that Edwin Rivera's presentation slides on ICH Q7A have now been made accessible to the public. On a total of 113 slides, Edwin Rivera has taken up the individual chapters of ICH Q7A. This compilation is very informative - not only for internal training purposes! Just click here in order to be shown the slides.

Upcoming events:

In co-operation with APIC, a sector group of CEFIC, the association of the chemical industry in Europe, we have just finalised 3 new programmes. They will be of special interest to all those who aim at ICH Q7A compliance. The parallel Education Courses:

take place in Lisbon, Portugal, on 27-29 January 2003. The speakers include 2 members of the ICH Q7A Expert Working Group. The parallel events ensure that specific knowledge is imparted to participants both from chemical and from biopharmaceutical API manufacturers. 

Each of the seminars can be booked together with the directly following auditor course. The number of participants of the Certified ICH Q7A Auditor is limited - as it as for the other two Education Courses. If you are interested in taking part, we recommend you to book early!