Biography:
Richard Denk is working at the company SKAN AG, headquartered in Allschwil in the position Senior Consultant Aseptic Processing & Containment. Richard is member of the PDA Isolator Expert Group and publisher of the PDA Paper “Isolator Surfaces and Contamination Risk to Personnel and Patient”. Furthermore, Richard is Member of the ISO TC 198 WG-9 Aseptic Isolator Group. Richard was on the Annex 1 and PIC/s Annex 2 commenting team of the ISPE, Richard founded 12 years ago the Containment expert group of the ISPE D / A / CH. The Containment Group published the Containment Manual Richard was responsible for in September 2015. Richard has spent more than 20 years with the subject on Aseptic Processing and highly active / highly hazardous substances and has developed the containment pyramid.
Title : Manufacturing outlook on cell and Gene and aseptic processing according the EU GMP Annex 1