ISPE Critical Utilities Conference Programme Leaders:
- Anders Vidov, Managing Director, Deltatec Pharma
- Katrin Åkerlindh, Business Operations Manager, Linde Healthcare, Region Europe North
Tuesday, 12 March 2013
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
11.15 – 12.00
12.00 – 13.00
US Pharmacopeia, European Pharmacopeia & Japan
Pharmacopeia Coordination – Current Status and Harmonisation
Anthony Bevilacqua, Mettler-Toledo Thornton, Inc.
Ozone Versus Hot Water Sanitisation
Nissan Cohen, Pharmaceutical Water Consultant and Lecturer
Lunch
WATER AND STEAM
13.15 – 13.45
13.45 – 14.30
14.30 – 15.00
Why Use Electrolytic Ozonation (Micro-Ozonation) Versus
Standard Ozonation through Practical Case Study
Robert Neri, Sanofi
Water For Injection
Giorgio Quaroni, Stilmas
Networking Break
PLANT VISITS
15.00 – 18.15
18.15 – 21.00
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
Networking Dinner
ISPE Critical Utilities Conference Programme Leaders:
- Anders Vidov, Managing Director, Deltatec Pharma
- Katrin Åkerlindh, Business Operations Manager, Linde Healthcare, Region Europe North
Wednesday, 13 March 2013
RISK AND CHALLENGES
08.00 - 08.30
Welcome Coffee
08.30 – 09.15
Rapid Microbiological Methods – Chances and Risks
Frank Panofen, Merck
Sampling of Water, Gases and Steam
Michael Vestermark, Novo Nordisk A/S
Networking Break
09.15 – 10.00
10.00 – 10.30
PROCESS GASES AND COMPRESSED AIR
10.30 – 11.15
11.15 – 12.00
12.00 – 13.00
Process Gases: User Requirements and Application of Risk
Assessment Techniques
Frank van der Steen, Frank Validation & Consultancy Services
Cryo Bio Nitrogen
Fredrik Bjärfors, Business Development Manager, Hospital
Services - Continental & Northern Europe, AGA Gas AB, Linde
Healthcare
Lunch
RISK AND CHALLENGES
13.00 – 13.45
13.45 – 14.30
14.30 – 15.15
15.15 – 15.45
15.45 – 16.30
16.30 – 17.30
17.30
Regulatory Inspections and Quality Expectations on Critical
Utilities in the Pharma Industry
Thomas Beck, Recipharm AB
Challenges in Eastern Europe
Jiří Moninec, Managing Director, G.M.PROJECT s.r.o.
Risk Management for Production and Distribution for Clean
Utilities
David Le Fort, Energy Strategy Manager, GlaxoSmithKline
Networking Break
Rouge the Intrinsic Phenomenon in 316L Stainless Steel, a
Key Material for Biopharmaceutical Facilities
Michelle Gonzalez, BioPharm Engineering Consultant
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
Conference Adjourns