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What do the EU GMP Annex 1 and the ISPE Baseline Guide Volume 8: Pharma 4.0™ (First Edition) have to do with each other?
Richard Denk
SKAN AG
Senior Consultant Aseptic Processing & Containment
Richard Denk is working at the company SKAN AG, headquartered in Allschwil in the position Senior Consultant Aseptic Processing & Containment. Mr. Denk founded 12 years ago the expert Containment group of the ISPE D / A / CH. The Containment Group published the ISPE Containment Manual Mr. Denk was responsible for in September 2015. He is Member of the ISPE SIG BioTech Group in Europe and Steering Committee Member of the ISPE SPP CoP. Since 2019 he is chair of the new founded ISPE- D / A / CH SIG Robotic Group. Mr. Denk is co Autor of the ISPE OSD Baseline Guide Volume 2 and Volume 3. Mr. Denk has spent more than 20 years with the subject production of highly active / highly hazardous substances and has developed the containment pyramid.
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