FPS, in collaboration with AFTI, is pleased to invite you to the free conference on the new versions of Annex 1 and ICH Q9 QRM: Regulatory Expectations and Inspection Findings in recent years. The event will take place on Tuesday 18 April from 14:00 to 18:00 in the “La Serra” room in Via Pian Scairolo 12CH-6915 Pambio Noranco, Lugano.
Program:
14:00 Attendee registration and AFTI greeting – Giovanni Mazzei
14:20 New Annex 1: a view of the key changes – Alberto Magnani
14:50 The new ICH Q9 QRM: what are the regulatory expectations and challenges? – Giovanni Cosmi
15:30 Coffee break
16:00 Innovative solutions for isolators and containment – Piero M. Laiso
16:30 Case Study – Design of Aseptic Isolators handling Toxic powder/liquid – Stefano Butti
17:15 Q&A
17:30 Aperitif offered
Language: Italian
Registration Deadline: For organizational reasons, please give your membership by April 7, 2023 by filling out the form below.
For more information: marketing@fps-pharma.com
Alberto Magnani – Leader in Pharma Quality Operations
Giovanni Cosmi – Senior Life Sciences Consultant (Chimico)
Piero M. Laiso – Senior Consultant, Process, Engineering
Stefano Butti – FPS – Technical Sales Director