Annual conference of ISPE® Affiliate of Czech Republic and Slovakia

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 L. Iskra (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  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

Conference sponsors:

Vimachem - https://www.vimachem.com/

Regom - https://www.regom.cz/

Compas - https://www.compas.cz/

GrapeNet - https://grapenet.cz/

Honeywell - https://www.spartasystems.com/