Annex 1 in practice 2026
The Aseptic Processing Community of Practice will continue its series of hands-on workshops on Annex 1 in November. Following SKAN in Basel in 2024 and Takeda in Linz last year, this time Boehringer-Ingelheim in Ingelheim is opening its doors to host a mix of presentations, workshops, and discussions on Annex 1.
On the first day (November 10), the workshops’ focus topics will be introduced: aseptic setup, single-use systems, and environmental monitoring in the context of Annex 1. The afternoon will be devoted to workshops on these topics.
A networking dinner in a lovely setting will round out the day.
On the second day (November 11), three presentations will provide input for an open discussion on the implementation of Annex 1. The discussions focus on First Air’s existing facilities, which are implementing CCS in light of the inspections and a case study on the measures taken to resolve an FDA CRL.
One of the highlights of the second day will certainly be the guided tour of the manufacturing facilities at Boehringer-Ingelheim.
The focus is on sharing experiences and discussing ideas for solutions. If the Q&A on Annex 1 of the PIC/S has been published by then, it will be referenced in detail.
Key Details
Target audiance
Students, as well as professionals and executives in management, research, manufacturing, quality assurance, and regulatory fields.
Date
November 10, 2026, 8:30 a.m. – November 11, 2026, 4:00 p.m.
Location
Boehringer-Ingelheim
Binger Straße 173
55216 Ingelheim an Rhein
Germany
Language
German.
Workshop size
The number of participants is limited to 40 in order to ensure an efficient exchange.
Participation fee
The fees are per participant:
450,- € for ISPE members
750,- € for non-members – This booking option includes a one-year ISPE membership.
Registration
The following button leads to the registration form: