Lessons learned from Annex 1 implementation
Learn from industry professionals how to implement new Annex 1 regulation. Full-day seminar with presentations/use cases (from Skan, J&J, Advipro, Ekium, GSK, UCB) and site tour at UCB plant.
Date: 23 November 08h00-18h30
Location – UCB, Braine-l’Alleud (access via Chaussée de Tubize - Parking P13).
Including lunch, networking drink, table top exhibition. Open for ISPE and non-ISPE members (reduced fee for ISPE members).
Agenda
8:00 - 9:00 Registration and coffee
9:00 - 9:10 Welcome (Wim Steenackers, President ISPE Belgium Affiliate)
9:10 - 9:45 Annex 1 implementation strategy, impact and key implementation plan
(Christophe Haenzler, GSK)
9:45 - 10:15 Annex 1: New requirements on Barrier and Transfers
(Richard Denk, SKAN) Remote presentation
10:15 - 10:45 Coffee break with table top & networking opportunities
10:45 - 11:25 Annex 1 implementation, sterilization requirements of direct and indirect product contact parts and Biodecontamination of RABS gloves
(Nico Schillebeekx, Benedicte Filez & Liselotte Vandenbussche, J&J)
11:25 - 12:00 Environmental Monitoring and Contamination Control Strategy (CCS).
(Alain Deloof & Nathan Decoster, Advipro)
12:00 - 13:30 Lunch with with table top & networking opportunities
13:30 - 14:05 Engineering and Facility Design: Practical Case Studies with Application of Annex 1
(Sylvie Alexandre & Paul Gillain, Ekium)
14:05 - 14:40 Challenges and opportunities in Annex 1 requirements interpretation when developing a CCS and internal standard
(Olivier Dupont, UCB)
14:40 - 15:00 UCB Visit introduction (Geoffrey Folie, UCB)
15:00 - 17:30 UCB Visit (Choice between 3 options: A. Inflexio Bio Plant - B. T2 Bio Pilot Plant - C. Finished Products (BMFP))
17:30 – 18:30 Closing of the day with networking reception
Special thanks to our sponsors:
🥇 QbD Group, PwC Belgium, Flow Technology Ltd
🥈 SKAN, KPC International, Siemens, BakerHicks, Agidens, ProSys Group, PMT Benelux, TCPS NV; Bürkert Fluid Control Systems