Comunicado. Hoy y mañana se estará llevando a cabo el Seminario de capacitación BFS IOA 2025 que está dirigido a usuarios/industrias de BFS y agencias reguladoras y se basa en el nuevo Documento PTC (Puntos de consideración) publicado en mayo de 2024.
Al ser una reunión abierta, las empresas operadoras de BFS que no sean miembros pueden asistir con hasta dos delegados por empresa de forma gratuita.
A continuación la agenda de ambos días:
April 9
8:30 Registration (Casa Dann)
9:00 Welcome and Introduction by the BFS IOA Board
9:15 Introduction, Background, and Basics of BFS Technology including resins and container examples PTC Section: 1; 3 ; 12 and 13 (Jesper Laursen, MELITEK)
9:45 Regulatory Aspects of BFS Production including new EU GMP Annex 1 (BFS Section) and Environmental Monitoring PTC Section: 2, 9 and 15
(Martin Haerer, Rommelag CMO)
10:45 Coffee & tea break
11:15 Overall BFS Design Considerations and PTC Section: 4 (Peter Akerman, AstraZeneca Sweden)
12:00 Keys to start a new BFS line including Layout Installations, Qualification and Validation and Sterile Filtration of BFS Installations including CIP and SIP PTC Section: 7 and 8 (Zhir Karem, AstraZeneca Sweden)
12:45 Regular operation and Data collection for BFS Manufacturing PTC Section: 9 and 10 (Zhir Karem, AstraZeneca Sweden)
1:00 Lunch
2:00 Leak Testing, Visual Inspection, physical in process controls PTC Section: 5 (Christophe Schwoehrer, Recipharm)
2:45 Secondary packaging of BFS containers including labelling PTC Section: 5 (Peter Akerman, AstraZeneca Sweden)
3:15 Coffee & Tea break
3:45 Autoclaving of BFS products including validation PTC Section: 6 (Peter Akerman, AstraZeneca Sweden)
4:30 Panel Discussion / Closing of Day 1
5:00 Leaving for social event & dinner at Tramonti Restaurante
April 10
8:30 BFS Machine Maintenance PTC Section: 11 (Christophe Schwoehrer, Recipharm)
9:15 Validation of aseptic fill process/Media fills PTC Section: 8 (Martin Haerer, Rommelag CMO)
10:30 Coffee & tea break
11:00 Filling of heat sensitive Products/Biologicals with BFS equipment (Christophe Schwoehrer, Recipharm)
11:30 Defect Library (all) including Q&A
12:15 Lunch
1:15 Workshop on CPP Introduction: 15 min. Workshop: 75 min. Lead: Zhir Karem, BFS IOA Technical officer (AstraZeneca Sweden)
4:15 Coffee & tea break
4:45 Conclusion (Jesper Laursen, BFS IOA Officer of Operation)
Más información: https://www.bfsioa.org/Events/Training-seminar-2025--Bogota-Colombia
Hoy también publicamos las siguientes notas y más...
FDA acepta solicitud del tratamiento de Teva para prevenir la migraña episódica pediátrica
