Workshop 11 - GE Healthcare - cGMP
Current GMP lifecycle and its implications in PET: Facilities Design, Manufacturing and Documentation

Location: Erato & Uranie
Date: Saturday, September 13, 2008
Time: 17:10-1840
Capacity: 440 Seats
Chairs: Simon Kinloch, Hernan Lara

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The goal of this workshop is to discuss the lifecycle application of current Good Manufacturing Practice guidelines and the implication of the latest revision of Annex 3 in PET.

17:10 – 17:30: Simon Kinloch (Quality Assurance Director at GE Healthcare) will open the workshop with a discussion on the clinical Trial Phases and License life cycle.

17:30 – 17:50: Martin Bradney (GMP Engineering Director at GE Healthcare) will speak about the theoretical model used to design, develop and maintain a PET facility under cGMP Guidelines.

17:50 – 18:10: Simon Kinloch will speak about the implications on a PET manufacturing facility with the latest revision of the Annex 3.

18:10 – 18:30: Dr. Ruairi O’Donnell (Erigal Group Operations Manager) will discuss his experience of applying for a PET Manufacturing license. In this discussion, Dr O’Donnell will focus on the challenges faced throughout the application process.

18:30 – 18:40: Panel Discussion. Interactive discussion of all speakers with attendees.