Industry Update Dinner

**Please note date was changed to November 9**

Come along to PharmOut’s Industry Update Dinner and catch up on the very latest topics and news! Join us for a delicious 3 course meal and enjoy an evening of “must know” topics and networking.

Entree

Computerised systems, GAMP5 second edition, IoT, AI, Machine Learning, non-linear validation 

The pandemic has accelerated digitalization, IoT devices are being installed at an alarming rate, GAMP 5 second edition now covers AI, Machine Learning, Blockchain and Pharma 4.0. Did you know that GAMP5 is silent on Operational Technologies (OT), the network IoT devices and other proprietary hardware and software operates on.

Trevor Schoerie – Managing Director – PharmOut

Main Course

EU GMP Annex 1

Ashley will be presenting all day on Annex 1 at the same venue, and as a sucker for punishment, Ash will keep going and cover the need to know aspects of the changes in Annex 1 that you may have been too busy to find out about.

Ashley Isbel, GMP Services Director, PharmOut

Dessert

ICH Q9

Did you know that once Annex 1 and Annex 20 are updated, the word “risk” will appear 871 times?  Currently in PE009-15, it only appears 645 times, enough to give you indigestion.

Maria will be sharing the 4 main changes and the 2 smaller changes in the new draft FDA version of ICH Q9.

Maria Mylonas, Learning and Development Director, PharmOut