





| Plenary Session | |
| 08.45 – 09.00 | Welcome, Introductions and Announcements - Overview & Meeting Objectives Anders Vidov, Managing Director, Deltatec Pharma Katrin Åkerlindh, Business Operations Manager, Linde Healthcare, Region Europe North |
| 09.00 – 10.00 | Keynote Presentation followed by Q&A Session Michelle Gonzalez, BioPharm Engineering Consultant |
| 10.00 – 10.30 | Networking Break |
| Regulatory | |
| 10.30 – 11.15 | US Pharmacopeia, European Pharmacopeia & Japan Pharmacopeia Coordination – Current Status and
Harmonisation Anthony Bevilacqua, Mettler-Toledo Thornton, Inc. |
| Water and Steam | |
| 11.15 - 12.00 | Ozone Versus Hot Water Sanitisation Nissan Cohen, Pharmaceutical Water Consultant and Lecturer |
| 12.00 - 13.00 | Lunch |
| 13.00 – 13.45 | Why Use Electrolytic Ozonation (Micro-Ozonation) Versus Standard Ozonation through Practical
Case Study Robert Neri, Sanofi |
| 13.45 – 14.30 | Water For Injection Giorgio Quaroni, Stilmas |
| 14.30 – 15.00 | Networking Break |
| Plant Visits | |
| 15.00 – 18.15 | Plant Visits: Novo Nordisk, Lundbeck, SSI Discussion forums related to Baseline Guides and exchange of ideas Ozone - Anders Vidov, Managing Director, Deltatec Pharma Gases - Katrin Åkerlindh, Business Operations Manager, Linde Healthcare, Region Europe North |
| 18.15 – 21.00 | Networking Dinner |
| Risk and Challenges | |
| 08.00 - 08.30 | Welcome Coffee |
| 08.30 – 09.15 | Rapid Microbiological Methods –
Chances and Risks Frank Panofen, Merck |
| 09.15 – 10.00 | Sampling of Water, Gases and Steam Michael Vestermark, Novo Nordisk A/S |
| 10.00 – 10.30 | Networking Break |
| Process Gases and Compressed Air | |
| 10.30 – 11.15 | Process Gases: User Requirements and Application of Risk Assessment
Techniques Frank van der Steen, Frank Validation & Consultancy Services |
| 11.15 – 12.00 | Cryo Bio Nitrogen Fredrik Bjärfors, Business Development Manager, Hospital Services - Continental & Northern Europe, AGA Gas AB, Linde Healthcare |
| 12.00 – 13.00 | Lunch |
| Risk and Challenges | |
| 13.00 – 13.45 | Regulatory Inspections and Quality Expectations on Critical Utilities in the Pharma
Industry Thomas Beck, Recipharm AB |
| 13.45 – 14.30 | Challenges in Eastern Europe Jiří Moninec, Managing Director, G.M.PROJECT s.r.o. |
| 14.30 – 15.15 | Risk Management for Production and Distribution for Clean Utilities David Le Fort, Energy Strategy Manager, GlaxoSmithKline |
| 15.15 – 15.45 | Networking Break |
| 15. 45 – 16.30 | Rouge, the Intrinsic Phenomenon
in 316L Stainless Steel, a Key Material for Biopharmaceutical Facilities Michelle Gonzalez, BioPharm Engineering Consultant |
| 16.30 – 17.30 | Industry Pharmacopeia & Regulatory Panel Anthony Bevilacqua, Mettler-Toledo Thornton, Inc. Thomas Beck, Recipharm AB Michael Higdon, Senior International Account Manager - EMEA, United States Pharmacopeial Convention (invited) And respective speakers |
| 17.30 | Conference Adjourns |
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