Workshop 06.02.2025, 13:00 - 17:00:
13:00 Opening (J. Melichar, M. Ugochukwu Monincová)
13:05 R. Čadek (Teva): Causes of human errors, tools for determining causes
13:35 J. Tengler (Medis International): Human errors
14:05 - 14:30 Coffee break
14:30 GrapeNet and Vimachem: Reduce deviations due to human errors through a Pharma Manufacturing Execution Platform - Practical Use Cases of Electronic Batch Records and Electronic Logbooks
15:00 M. Ugochukwu Monincová: Microbiological results - what can be human error, what is nature, what is process
15:30 oncomed: Human errors - case study, examples from practice
16:00 - 17:00 Questions, answers, experiences, discussions
18:00 Social event with dinner at the Cosmopolitan Hotel
Conference 07.02.2025 9:30 - 16:00:
9:30 Opening
9:30 Ing. Jiří Melichar: ISPE Affiliation, Information on the status of Affiliation 2024
9:45 ISPE Board Member introduction
10:00 D. Vetchý (Faculty of Pharmacy, MU, Brno): Vision and cooperation with FaF
10:30 - 11:00 Coffee break
11:00 M. Černý, V.Klíma, V. Braun (Compas) - Biotechnological process control, commissioning and validation
11:30 P. Říha (Process Automation Solution): Validation of IT infrastructure in a GxP environment
12:00 – 13:00 Lunch
13:00 E. Halaška (Regom): Mixing, homogenization, dissolution of powders into liquids + practical examples and advice for commissioning and qualification
13:30 A. Kappani – Glove qualification (on-line)
14:00 -14:30 Coffee break
14:30 Doris Raith (Honeywell): Risk management - antidote for human errors
15:00 M. Janků: Industrial hygiene (how to safely handle hazardous substances in production and laboratory)
15:30 - 16:00 Conclusion, questions, answers, discussion
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