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.
Tracy Moore, Founder & CEO, TM Pharma Group, UK
Tracy Moore is an accomplished quality professional with over 35 years of experience in pharmaceutical manufacture, distribution and regulation gained from working within the industry and for the GMP Inspectorate of the UK medicines regulator (MHRA), where she reached Expert Inspector level/status. During her ten years as a GMP Inspector, Tracy had responsibility for licensing and inspection of pharmaceutical manufacturers and distributors both in the UK and overseas, the development and implementation of regulations and European guidelines relating to pharmaceutical manufacture and distribution, the management of risk and noncompliance in these sectors and collaboration with other European and International regulatory authorities.
Tracy was a drafting member of the MHRA EU PICS GMP Annex 1 document in addition to Annex 16 and Annex 21 and the MHRA GXP data Integrity lead, publishing the 2018 guidance document.
Tracy set up the MHRA's inspector academy in 2020, which allowed for an efficient accreditation of MHRA inspectors and assessed Member States ' inspectors' competence through the Joint Audit Programme for EU.
Before MHRA, Tracy spent 22 years working in the pharmaceutical industry's commercial and R&D environments in QA, EUQP and management roles covering sterile and non-sterile product dosage forms, including biologics and oral vaccines.
Registration Fee:
Member: SGD 38+GST
Non-member: SGD 88+GST