Training: Annex 1 Implementation and First Inspector Finding
24 Apr 2025 | 8.30am–5.00pm SGT
The Chevrons, 48 Boon Lay Way, Singapore 609961
Agenda:
8:30 Introductions
9:00 Annex 1 Implementation and First Inspector Finding
9:45 Group Discussion on CCS and First Air, and Indirect Product Contact Parts
10:30 Break
11:00 Barrier as RABS – Isolators, Decontamination and Gloves
11:45 APS Introduction
12:15 Group Discussion on APS
13:00 Lunch
14:00 Group Discussion on Material Transfers
14:45 Introduction of EM
15:15 Group Discussion of EM
15:45 Break
16:15 Future Robotics and Fully Automated System
16:45 Closure
17:00 End
Led by:
Richard Denk, Senior Consultant Aseptic Processing & Containment, SKAN AG
Richard Denk is working at the company SKAN AG, headquartered in Allschwil - Switzerland in the position Senior Consultant Aseptic Processing & Containment. Richard was member of the Annex 1 - ISPE Commenting Team and is past chair of the ISPE European Affiliate Council, chair of the Future Robotics of the ISPE DACH and Board Member of the ISPE DACH (Germany/Austria/Switzerland).
Richard is co-Author of several ISPE Guidelines like for Pharma 4.0, OSD, Containment etc. and frequent international speaker. Richard did a world tour on Industry and Regulatory Trainings on Annex 1 Implementation during the last 2 years and discussed this topic with more than 15000 people globally.
Richard has spent more than 30 years with the subject on Aseptic Processing and highly active / highly hazardous substances and has developed the containment pyramid.
Richard Denk is working at the company SKAN AG, headquartered in Allschwil - Switzerland in the position Senior Consultant Aseptic Processing & Containment. Richard was member of the Annex 1 - ISPE Commenting Team and is past chair of the ISPE European Affiliate Council, chair of the Future Robotics of the ISPE DACH and Board Member of the ISPE DACH (Germany/Austria/Switzerland).
Richard is co-Author of several ISPE Guidelines like for Pharma 4.0, OSD, Containment etc. and frequent international speaker. Richard did a world tour on Industry and Regulatory Trainings on Annex 1 Implementation during the last 2 years and discussed this topic with more than 15000 people globally.
Richard has spent more than 30 years with the subject on Aseptic Processing and highly active / highly hazardous substances and has developed the containment pyramid.
Registration Fee:
Member
SGD 88+GST
Non-member
SGD 188+GST before 24 March
SGD 238+GST from 24 March