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This presentation will highlight the requirements for data management in the light of sterile manufacturing. The inspector will share experiences with the implementation of Annex 1 in reference to Chapter 4 and Annex 11 based on new developments in the field. They will highlight expectations on successful contamination control strategy implementation and on data driven manufacturing processes and quality oversight.

This facility tour is sold out and will not be accepting additional registrants.

Buses will depart at 9:00 AM EDT outside the front of the Westin Boston Seaport District Hotel at the corner of D street and Fargo street (exit through the concourse level). We ask that attendees be downstairs, looking for an ISPE team member by 08:45 at the latest. 

Participants will view a brief presentation on ElevateBio and then tour the BaseCamp Waltham facility with members of the leadership team. Refreshments and Q&A to follow.

Included in your In-Person All Access Pass! Don't miss out on the chance to connect, indulge, and unwind at the ISPE Europe Annual Conference! Dance to the beats of our DJ or mingle and network. Join us for an unforgettable evening of networking, delicious food, and delightful entertainment!

Description Coming Soon!

An orientation for ISPE Foundation Professional Development Grant recipients to gain insight on how to maximize their conference experience.

Separate registration through the affiliate required. To learn more and register, visit this link:  Reception Registration

Join the ISPE Italy Affiliate for a Networking Reception on Tuesday, 10 December 2024 from 8 PM CET.

Location: 
MAIO Rooftop
Via del Tritone 61 (Rinascente, 6° & 7° floor)
00187 Rome - Italy

Registration open: Wednesday, 11 December 0800-1700 CET.