Datum i mjesto održavanja skupa:
- 10.06.2025. u 08:15 sati
- Slovenija, Terme Olimia, Podčetrtek
Način prijave:
- putem poveznice
Iznos kotizacije:
- kotizacija iznosi 160€ + PDV
Program stručnog skupa:
- Isolator gloves - Challenges, Solutions and Innovations
Topic: R&D - How to select the right isolator glove
Focus: Integrity testing, traceability of gloves, and positional considerations - Testing of RABS gloves: Application and visual inspections in the context of the new GMP Annex 1 (CCS)
Topic: Important aspects of control and validation in the application of RABS (Restricted Access Barrier Systems) in the pharmaceutical industry.Latest guidelines related to RABS glove testing, using both device-based and visual methods. Best practices - Design of Controlled Clean Rooms (CR)
- Appropriate classification of CRs based on the final product
- Personnel and material flows (Unidirectional flow).
- Architecture considerations – pressure cascades, sink bubble design, and application consideration for radiopharmaceuticals
- Protective measures and security
- Computer-aided systems
- "Real- life" challanges and examples
- Regulatory updates in GMP in the Adriatic region
- Risk Assessment
- Strategies and experiences in the Equipment Qualification
- Implementation of the VR Simulator into an existing training system in Controlled environment
- How is an implementation structured?
- Defining qualification levels for individuals – from newbie to senior operator – and link them to application areas for training and the training- and qualification matrix
- Module selection process: The module selection procedure is a multi-stage process for making the best possible selection of VRS modules
- Creating learning objectives to assess the learners’ level of knowledge
- Module-Fit-Analysis matches the content of VR modules with current procedures and MBRs in operations
- Microbiology and Mediafill Testing
- Focus: Mediafill test and microbiology considerations - rules of enviormetal monitoring
- Future of QC testing using automation & robotics
- Topic: Advantages & requirements of QC automation in regulated environments
- Introduction of automated air sampling solution in classified cleanrooms with mobile robot
- Ready-to-use solution for traditional EM for fill and finish in gloveless isolators, improving traceability and safety
- Topic: Advantages & requirements of QC automation in regulated environments
- Transfer of Materials in Cleanroom Environments in correlation to Annex 1 guidelines
- Topic: Transfer of the material
- Annex 1 Guidelines: The Importance of Nitrile Gloves in Aseptic Processes
- Practical Workshops
- Workshop 1
- Topic: CCS strategy - Using UV powder and light on the Qube isolator – practical case study
- Workshop 2
- Topic: Residue management – practical case study
- Workshop 1