Richard Denk

Richard Denk is working at the company SKAN AG, headquartered in Allschwil Switzerland in the position Senior Consultant Aseptic Processing & Containment. Richard is Member of the PDA ATMP Advisory Board and chair of the PtC of the Manufacturing of ATMPs. 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 ISPE Annex 1 and PIC/s Annex 2A commenting group, Founded the ISPE CoP Containment and SIG Future Robotics. Richard is Member of the ISPE European Leadership Team and Member of the ISPE CoP Sterile Product Processing. Richard is a global recognized subject matter expert on Aseptic Processing, ATMPs and Containment and has developed the containment pyramid.

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Thu. February 23 | 08:30am – Annex 1 – GMP Compliance when working with Robotics in Aseptic Processing

• What is new in the Annex 1 and why is automation important to increase the safety for sterile Pharmaceuticals.
• Case Study on a fully automated gloveless aseptic filling line in compliance with the new EU GMP Annex 1.
• Outlook on Robotics in aseptic manufacturing.